• Serve as an advisor and consultant to the Commander and Executive Officer.
• Recommend policy and system changes.
• Act as the program manager and subject-matter expert (SME) for virtual communities, and business collaboration for Naval Hospital Camp Pendleton and subordinate organizations.
• Serve as Vice Chairman and coordinator to the Quality Care Council.
• Serve as Department Head of Quality Management.
• Oversee the day-to-day use of the purchase cards assigned to cardholders.
• Perform other duties as assigned.

The PAI receives administrative direction from management in terms of broadly defined missions or
functions. The PAI, mostly independently plans, designs, and carries out programs, projects, studies, or
other work. The PAI provides policy assistance to field level Aviation Safety Inspectors (ASIs) on
difficult or complex policy interpretations. The work is normally accepted without change. Completed
work may be reviewed for adherence to FAA policy and for assurance that project requirements have been
fulfilled.

ASIs at the FG-13 level issue certificates to and monitor (1) a large and complex aviation organization or
(2) a number of smaller organizations that, together, are comparable in complexity to one large one. They
are the primary contact point with the aviation organization(s). They may decide on issuance of the original
certificates. They evaluate and decide upon proposals to change the authorized programs of the
organizations. They continuously monitor the activities of organizations to determine whether they are
following their authorized program, Federal regulations, and good safety practices

FG-13 assignments are characterized by one or more of the following:

1. Commercially operated aircraft or and the complex avionics equipment associated with such
2. A variety of maintenance operations with diverse types of aircraft; or
3. Novel and complex aviation operations.

FG-13 employees plan and conduct their assignments with substantial technical independence. They receive administrative and policy guidance from their supervisors and policy makers. They also obtain technical advice from higher-level inspectors who are experts on a particular type of aircraft or who have overall program responsibility. They independently plan and carry out a work program to meet the needs and monitor the activities of the organizations for which they have certification responsibility. The scope and complexity of the work program may be such as to require the occasional assistance of other employees to conduct inspections and evaluate operations.

The PAI applies a mastery knowledge level of the appropriate specialization and a broad knowledge of the
mission and goals to assigned programs and areas of responsibility.

The PAI plans and directs the use of time and resources to accomplish organizational objectives. He or she
defines, organizes, and uses resources to accomplish work activities within established schedules, analyzes
program requirements and accomplishments, and makes or directs adjustments as necessary to address organizational needs.

Guidelines and precedents are frequently inadequate for dealing with novel or complex operations.
incumbent understand and apply the basic principles of aviation safety and interpret the intent of
the regulations.

Contacts are frequently with owners and top managers of aviation corporations and involve
negotiating and resolving the full range of issues and problems that confront aviation organizations.
Occasionally issues are controversial, arousing considerable public interest.

ASIs at the FG-13 level participate extensively in the certification inspection and surveillance of highly
complex air carrier operations where principal program responsibility is vested in an aviation safety inspector
of higher grade. Employees have broad authority to negotiate with carrier management and
make technical determinations within the coverage of approved specifications and policy manuals.

The PAI provides guidance to field level staff to solve difficult technical issues. Resolves all but unique
problems, with the intervention of management or a more experienced technical specialist. Develop plans,
techniques, and policies to address current and anticipated problems and issues.

The PAI is expected to follow established laws, order, policies and regulations that provide general guidance for completing work adjectives but is allowed discretion to develop new or innovative approaches.

Performs other duties as assigned.

• Performs duties associated with the administration of the quality assurance provisions of contracts by designing, implementing, and maintaining a risk-based surveillance program and assessment plan.
• Identifies opportunities for process improvements through analysis of process measurement data.
• Serves as a member of a multi-functional or technical team. Responsible for implementing the overall Quality Program for a diversity of products and services in support of U.S. Government acquisition at one or more supplier’s facilities.
• Ensures contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Independently performs audits/surveillance of contractor’s processes to ensure customer and contractual requirements are met.
• Investigates and provides data on customer complaints/concerns regarding contractor’s quality performance and processes which impact user satisfaction.
• Provides technical support to all other DCMA team members, assisting in the analysis of contract related issues to determine the best course of action to support the contractor and customers.

If selected for this position, you will be responsible for planning, directing and conducting complex investigations of suspected fraud, waste, and abuse, and mismanagement in programs of DOT, as well as a variety of proactive investigations, including fraud prevention and detection surveys. You will determine the scope and depth of the investigation, analyze and evaluate evidence; and on the basis of findings, prepare investigative reports. Investigations require frequent travel and may occasionally require undercover and surveillance work. Investigations will typically involve violations of the Department's programs and regulations with respect to contract and grant fraud, illegal transportation of hazardous materials, aviation safety, and motor carrier safety. Results of investigations may form the basis for criminal or civil prosecution by the Department of Justice; withholding funds from a state or grantee; administrative personnel actions by DOT; or changes in practices and/or procedures by DOT.

$1,000 First-Year Bonus*

Fairfield is looking for an experienced Community Compliance Specialist to join their team. Stratton Apartments has 312 units and is located in San Diego.

OUR COMPANY:

At Fairfield, we are proud to be a leader in the multifamily housing industry. We are passionate about creating exceptional and luxurious apartment living. Among the most experienced multifamily companies, Fairfield has developed and acquired over 1000 communities since 1985.  We are an award-winning company that proudly employs over 1,400 associates who are dedicated to serving our customers at our apartment communities located in over 30 markets nationwide.

Being a part of Fairfield means more than a rewarding career with personal growth. It’s a partnership for the long term, working alongside colleagues in an open-dialogue environment that encourages growth and the sharing of ideas. We know that our associates are a key ingredient to our success, and we’re proud to reflect that in our culture.

ABOUT THIS POSITION:

Our Community Compliance Specialists serve as a source of compliance knowledge for our affordable communities.  The property team relies on them for their understanding of the local, state and federal laws and regulations relevant to affordable multi-family housing. Successful associates in this role show a special level of dedication to integrity and compliance and are superior communicators. They are deeply committed to and enjoy collaboration and are able to ingratiate themselves with colleagues.

WHAT YOU CAN EXPECT TO DO IN THIS ROLE:

DOCUMENTATION

• Manage Tax Credit, HAP, RAP and/or Section 8 based files.

• Manage the annual recertification process for on time file completion.

• Process all certification documents including 3rd party verifications and appropriate state and federal forms.

• Scan and upload file documents. 

CUSTOMER SERVICE

• Handle inbound and outbound phones calls and written correspondence related to compliance.

• Offer support and assist with one-on-one training with on-site staff. 

MONITORING & ASSESSMENT

• Complete final evaluation and analysis of completed application package and prepare file for approval.

• Communicate with Maintenance Supervisor and Community Manager to ensure all turnovers and inspections are completed on time, prior to move-in.

• Perform routine audits of all on-site programs files and assist in correcting problem areas with the Community Manager.

COMPLIANCE

• Remain up-to-date on compliance procedures and training.

• Assure that all compliance requirements made by Monitoring Agencies are adhered to.

• Complete company required training by established deadline.

• Comply with all Fairfield standards, applicable health and safety rules and regulations, as well as applicable local, state and federal laws.

WHAT YOU WILL NEED ON DAY ONE:

• High school diploma or equivalent experience.

• Minimum of one year Tax Credit, Housing Assistant Programs (HAP), Rental Assistance Programs (RAP) and/or Section 8 compliance experience required.

• Strong knowledge of Yardi or other property management accounting software.

• Strong understanding of how TRACS integrates with Yardi, as needed on a HUD property.

• Knowledge of Microsoft Outlook, Word, Excel.

• Superior customer service skills including the ability to manage difficult customers and/or situations.

• Strong attention to detail, organizational, time-management, and problem-solving skills.

• Detail oriented; ability to manage conflicting priorities and to adjust priorities on a daily basis.

• Professional verbal and written communication skills.

• Able to reach deadlines independently.

*The First-Year Bonus, less usual deductions, will be divided into two equal payments: the first payment following the completion of 90 days of employment, and the second payment following the completion of 1 year of employment.

#LI-CAROLYN

#IN-CAROLYN

Estimated Rate of Pay:

$20.00 - $25.00

This position is non-exempt; the range above reflects hourly rates.

The pay range displayed for this position is determined by skills and experience required, location and job complexity*. Potential job offers may vary based on the skills, education, and experience an individual candidate holds. This range reflects base rate only, and does not include allowances, perks, commissions or bonuses applicable to this position (if any). In addition to base salary, Fairfield offers all full time associates the following, upon meeting eligibility requirements: 

• Paid time off, paid holidays and sick days, paid time off for volunteering activities (optional) 
• Matched 401(k) 
• Medical, dental & vision insurance 
• Flexible spending account 
• Life insurance 

* Pay range is a calculation based on a midpoint price. Fairfield complies with all wage and hour laws, including minimum wage and salary exempt requirements.  

Company Overview

Nashville, Tenn.-based Bridgestone Americas, Inc. is the U.S. subsidiary of Bridgestone Corporation, the world's largest tire and rubber company. Bridgestone Americas and its subsidiaries develop, manufacture and market a wide range of Bridgestone, Firestone and associate brand tires to address the needs of a broad range of customers, including consumers, automotive and commercial vehicle original equipment manufacturers, and those in the agricultural, forestry and mining industries. The companies are also engaged in retreading operations throughout the Western Hemisphere and produce air springs, roofing materials, and industrial fibers and textiles. The Bridgestone Americas family of companies also operates the world's largest chain of automotive tire and service centers.Guided by its global corporate social responsibility (CSR), commitment 'Our Way to Serve,' Bridgestone embraces its responsibility as a global leader by striving to improve the way people move, live, work and play.

• Leads projects or processes of diverse scope, while working independently with limited supervision
• Coaches and reviews the work of lower level professionals
• Supports continuous improvement/automation activities
• Uses advanced analytical/technical problem solving to develop new solutions to existing problems/procedures
• Supports relationships through strong communication and negotiation skills with internal and external stakeholders
• Other duties as assigned

We are relentlessly focused on empowering you with unique opportunities to make a meaningful impact and help shape your career. What really matters at Bridgestone is providing our teammates with the tools, support and autonomy to ensure you feel fulfilled and have clear direction to reach your goals. We offer a variety of experiences to help you build the career that matters to you.

The Ideal salary range for this position is a base salary of $95K with a total compensation target of $104,500.00.

Typically requires a minimum of 5 years of related experience with a bachelor’s degree; or 3 years and a master’s degree; or a PhD without experience; or equivalent work experience 

Bridgestone is proud to be an Equal Employment Opportunity / Affirmative Action employer.  It is our policy to consider for employment all individuals regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, gender, sex, sexual orientation, gender identity and/or expression, genetic information, veteran status, or any other characteristic protected by federal, state or local law.

Employment Eligibility

If hired, a Form I-9 Employment Eligibility Verification must be completed at the start of employment. Temporary work authorization or the need for sponsorship may disqualify you from employment.

Social Worker Quality Assurance Specialist - Community Services

Salary Range: $60,385 - $72,462 Annually

GGRC is currently hiring for a Quality Assurance Specialist. This role evaluates and monitors residential, day and specialized services within Agency’s three counties to ensure the quality of services provided to people supported to and in compliance with Title XVII, California Code of Regulations, Agency standards and best practices for programs.

This is a Hybrid flex schedule role offering the opportunity to work in the community, from any of our offices located in San Francisco, San Mateo and Marin County and from the comfort of your own home.

What you’ll Do:

• Coordinates and conducts quality assurance evaluations on community programs, including writing evaluation reports, conducting follow-ups, and providing ongoing monitoring
• Acts as an independent evaluator, as an evaluation team leader, or as a QA team member
• Participates in State reviews of GGRC services
• In coordination with other staff, revise evaluation tools for residential and nonresidential programs as needed based upon working knowledge of Title XVII regulations and best practices in the field
• Analyze and review changes in relevant sections of Title XVII and XXII and DDS standard regulations and makes policy recommendations as appropriate
• Participates in the Request for Proposal process for service provider selection as needed
• Develops plans of correction for underperforming programs as needed and provides follow up
• Serve on in-house and community committees and task forces to improve quality of community programs
• Provide specialized training workshops in evaluation and monitoring for service providers, GGRC staff, and community representatives
• Participates in meetings with Community Care Licensing and other regional centers
• Evaluate a Family Homes Agency (FHA) once a year and provide ongoing technical assistance to the FHA
• Provide technical assistance to community programs, including targeted training seminars
• Participate in special projects, and assist with additional duties or tasks as assigned

Who You Are:

• Ability to collaborate with a broad spectrum of providers and community partners
• Communication of technical requirements (policies, procedures, regulations and expectations) to diverse groups
• Problem identification and analysis
• Ability to interpret guidelines and standards and apply them in a fair and consistent manner
• Active listening
• Adaptability
• Collaboration/Teamwork
• Customer service orientation
• Organizational skills
• Time management
• Self direction

• Bachelor’s Degree from an accredited school of social welfare or related human services field with Master’s Degree preferred
• 2+ years post-graduate work, one of which must be in the field of developmental disabilities
• Experience with managing or working with programs for developmentally disabled

What are the benefits to working with GGRC?

Generous Tuition Reimbursement Program that reimburses qualifying employees up to $10,000 per fiscal year.

We offer a comprehensive benefits package including Medical and Dental benefits with a generous employer contribution and additional employer paid Life, Disability and Vision coverage

10% employer contribution to a 403(b) retirement account to help you save for the future!

GENEROUS TIME OFF BENEFITS!!!

No really, we mean generous:

13 vacation days, 15 sick days, 10 paid holidays, 4 personal holidays, 3 winter holidays, and up to 5 paid days for continuing education

What makes GGRC so special?

GGRC values diversity, we believe in creating an environment where people of all backgrounds can collaborate to find solutions to complex problems. We are community minded and passionate.

GGRC values each person as a full, robust, and unique individual and interacts with each person in a manner that is respectful and responsive. We endeavor to place each person at the center of his, her or their own life. We approach each person as an expert on his, her or their own life and identity with a clear and attentive inquiry into what is important to, as well as important for, that one person (whether coworker or person-served, family member or other stakeholder).

How to apply:

GGRC values diversity; people of all backgrounds are encouraged to apply. Please complete the application and submit your most recent resume. If you feel that the questions do not accurately capture what you have to offer Golden Gate Regional Center, you are also welcome to attach a cover letter. Applications are being reviewed on a rolling basis so we encourage you to submit yours soon. We look forward to reading your application.

Golden Gate Regional Center is an Equal Opportunity Employer.

Employees are required to have the Covid-19 vaccine unless they have a religious or medical exemption.

Position Overview

In this role, you will implement strategies and operational improvements for the Volume businesses of Global License Compliance (GLC). Your responsibilities will include coaching the GLC sales personnel, managing third-party organizations, and ensuring the efficient operation of the North American business.

Reporting to the Senior Director of GLC, AMER, you will also develop business processes and strategies to exceed Autodesk GLC's key objectives for its North American Territory Sales. Working collaboratively with the executive staff and key internal stakeholders, you will drive policies and programs in line with the organization's strategic and operational priorities.

Responsbilities:

• Monitor the policies, practices and processes of GLC North America to determine efficiency and effectiveness. Recommend improvements and develops strategies to achieve and deliver improved results. Implement and follow standards as defined by Corporate and Division senior management; escalate exceptions or questionable practices to direct manager or senior management staff. This may include working with various data support teams, legal, PPL, and Corporate Compliance.
• Regularly interact with executives and/or major customers. Interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization.
• Manage and lead a team of top accomplished License compliance sales professionals to exceed assigned quotas, ensuring team efficiency and revenue goals are met. Responsible for the hiring, team effectiveness, culture, performance management and skill development of this team.
• Deliver timely and accurate forecasting of the business, within 2% variance, and pipeline management.
• Manage and develop resources (including consultants, vendors and remote workers, which may be in different time zones). This includes selection, mentoring/coaching, performance management and assessment, and rewards and recognition within own team.
• Work on complex issues where analysis of situations or data requires an in-depth knowledge of Autodesk, its licensing models, and industry best practices. Participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensure budgets and schedules meet corporate and divisional requirements.
• Lead or sponsor cross functional or intra-divisional projects for Global License Compliance North America, especially projects related to streamlining and/or improving processes and systems.
• Lead the way in working collaboratively with Territory sales teams on account planning activities to ensure the best customer experiences.
• Manage sales KPIs, pipeline and activity metrics (all leading indicators) of team to ensure these are tracking towards achievement of revenue goals, while ensuring that a balance of sales and enforcement activity is maintained.
• Strategically monitor and review long term goals of the program and ensure campaigns are executed within budget and that License Compliance revenue targets are met.
• May make presentations to existing and prospective customers about the benefits of Autodesk software and engage in final stage negotiation with C level customers and be a point of escalation.
• Manage both Direct and Indirect sales motions.
• Manage a complex volume business that may include highly technical lead sources; responsible for prioritizing various lead programs for the team to maximize effectiveness of the business.
• Collaborates on best practices and drives License Compliance strategies with other geographies and functional groups.

Minimum Qualifications

• 10+ years of relevant experience in technical software or SAAS/PAAS sales; 5+ sales leadership experience with track record of creating high-performing teams.
• Sales experience includes track record of success in difficult negotiations with C-level, handling accounts in the enterprise segment, and conflict resolution.
• Experience in effectively managing a complex, volume-based and digital business and comfortable interfacing with stakeholders at all seniority levels.
• Familiarity with technology, licensing models, and business trends in Autodesk target industries.

Preferred Qualifications:

• Experience or knowledge in Cyber security practices or License Compliance industry
• Experience selling in value-based models
• Ability to build relationships at multiple levels
• Self-motivated with the ability to adapt to changing priorities and business initiative

About Autodesk

Welcome to Autodesk! Amazing things are created every day with our software – from the greenest buildings and cleanest cars to the smartest factories and biggest hit movies. We help innovators turn their ideas into reality, transforming not only how things are made, but what can be made.

We take great pride in our culture here at Autodesk – our Culture Code is at the core of everything we do. Our values and ways of working help our people thrive and realize their potential, which leads to even better outcomes for our customers.

When you’re an Autodesker, you can be your whole, authentic self and do meaningful work that helps build a better future for all. Ready to shape the world and your future? Join us!

Benefits

From health and financial benefits to time away and everyday wellness, we give Autodeskers the best, so they can do their best work. Learn more about our benefits in the U.S. by visiting https://benefits.autodesk.com/

Sales Careers

Working in sales at Autodesk allows you to build meaningful relationships with customers while growing your career. Join us and help make a better, more sustainable world. Learn more here: https://www.autodesk.com/careers/sales

Equal Employment Opportunity

At Autodesk, we're building a diverse workplace and an inclusive culture to give more people the chance to imagine, design, and make a better world. Autodesk is proud to be an equal opportunity employer and considers all qualified applicants for employment without regard to race, color, religion, age, sex, sexual orientation, gender, gender identity, national origin, disability, veteran status or any other legally protected characteristic. We also consider for employment all qualified applicants regardless of criminal histories, consistent with applicable law.

Diversity & Belonging

We take pride in cultivating a culture of belonging and an equitable workplace where everyone can thrive. Learn more here: https://www.autodesk.com/company/diversity-and-belonging

Are you an existing contractor or consultant with Autodesk?

Please search for open jobs and apply internally (not on this external site).

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Associate Quality Complaints - Lab

Live

What you will do

Let’s do this! Let’s change the world! The Senior Associate in Quality Assurance at Amgen plays a crucial role in maintaining high-quality standards across the manufacturing processes. They lead audits, address quality issues, develop training materials for QA procedures, and ensure compliance with both internal guidelines and external regulations.

Amgen is seeking a Sr. Associate Quality Complaints – Product Complaints Return Lab, supporting the Product Complaints and Surveillance Team. The Product Complaints and Surveillance team owns and carries out the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Sr. Associate evaluates complaint related return unit samples. Maintains the product complaint laboratory in compliance with Good Laboratory Practices (GLP). Performs work in a manner consistent with GLPs. Executes day to day operations in the product complaint laboratory and ensures the daily workload is completed efficiently and with high quality (e.g. PMs, calibrations, and general servicing).

Key Responsibilities:

• Applies analytical skills to evaluate product complaint return samples using multiple sources of information

• Manages work in accordance with Good Laboratory Practices (GLPs)

• Interprets SOP requirements

• Identifies product quality and safety risk with product complaint return samples

• Provides technical advice on complaint investigations

• Provides subject matter experts assessments (Return Unit Inspections)

• Partners with FPT on return sample evaluations, establishing inspection criteria and inspection method.

• Performs return inspection for complaints

• Supports product security inspections as needed

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

Master’s degree OR

Bachelor’s degree and 6 months of Quality experience OR

Associate’s degree and 2 years of Quality experience OR

High school diploma / GED and 4 years of Quality experience

Preferred Qualifications:

• Quality and manufacturing experience in biotech or pharmaceutical industry

• Bachelor’s Degree in a Science Field

• Ability to successfully manage workload to timelines

• Familiarity with basic project management tools

• Demonstrated ability to consistently deliver on-time, and high-quality results

• Ability to operate in a matrixed or team environment

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Associate Quality Complaints - Lab

Live

What you will do

Let’s do this! Let’s change the world! The Senior Associate in Quality Assurance at Amgen plays a crucial role in maintaining high-quality standards across the manufacturing processes. They lead audits, address quality issues, develop training materials for QA procedures, and ensure compliance with both internal guidelines and external regulations.

Amgen is seeking a Sr. Associate Quality Complaints – Product Complaints Return Lab, supporting the Product Complaints and Surveillance Team. The Product Complaints and Surveillance team owns and carries out the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Sr. Associate evaluates complaint related return unit samples. Maintains the product complaint laboratory in compliance with Good Laboratory Practices (GLP). Performs work in a manner consistent with GLPs. Executes day to day operations in the product complaint laboratory and ensures the daily workload is completed efficiently and with high quality (e.g. PMs, calibrations, and general servicing).

Key Responsibilities:

• Applies analytical skills to evaluate product complaint return samples using multiple sources of information

• Manages work in accordance with Good Laboratory Practices (GLPs)

• Interprets SOP requirements

• Identifies product quality and safety risk with product complaint return samples

• Provides technical advice on complaint investigations

• Provides subject matter experts assessments (Return Unit Inspections)

• Partners with FPT on return sample evaluations, establishing inspection criteria and inspection method.

• Performs return inspection for complaints

• Supports product security inspections as needed

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

Master’s degree OR

Bachelor’s degree and 6 months of Quality experience OR

Associate’s degree and 2 years of Quality experience OR

High school diploma / GED and 4 years of Quality experience

Preferred Qualifications:

• Quality and manufacturing experience in biotech or pharmaceutical industry

• Bachelor’s Degree in a Science Field

• Ability to successfully manage workload to timelines

• Familiarity with basic project management tools

• Demonstrated ability to consistently deliver on-time, and high-quality results

• Ability to operate in a matrixed or team environment

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Do more with the knowledge you’re working hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Through this program, you will acquire the valuable hands-on skills and foundational experience to become the professional you are meant to be in your chosen field.

Global Quality Compliance Undergrad Intern

Live

This could be your everyday

Let’s do this. Let’s change the world. During this program, you will be working closely with the quality compliance team to help prepare to prepare the global auditing processes for migration into a new electronic system. You will have the opportunity to immerse yourself in learning drug/combination product/medical device auditing regulations while helping to streamline and simplify processes.

• Assist in Gathering User Requirements
• Help to Develop Workflows
• Redline and Process Procedural Updates
• Establish Standardized Forms, Reports
• Help to Plan and Execute Workshops

Win

Here’s what it takes to Win

We are all different, yet we all use our unique contributions to serve patients. The quality minded individual we seek is detail orientated with these qualifications:

Basic Qualifications

Amgen requires that all individuals applying for a grad internship or a co-op assignment at Amgen must meet the following criteria:

• 18 years or older
• Currently enrolled in a full-time Bachelor’s Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent
• Completion of one year of study from an accredited college or university prior to the internship commencing
• Enrolled in a full-time Bachelor’s degree program following the potential internship or co-op assignment with an accredited college or university
• Must not be employed at the time the internship starts
• Student must be located in the United States for the duration of the internship

Preferred Qualifications

• Degree concentration(s) in life sciences or engineering.

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth in addition to their well-being:

The base pay range for this opportunity in the U.S. is $24.70 - $28.30.

• Build a network of colleagues that will endure and grow throughout your time with us and beyond.
• Bring your authentic self to the table and become the professional you’re inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
• Participate in executive and social networking events, as well as community volunteer projects.

Apply now

for an internship/co-op that defies imagination

If you feel like you're part of something bigger, it's because you are. Join us.

careers.amgen.com Please search for Keyword R-170795

#NBMBAA

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Material Compliance Associate

Live

What you will do

Let’s do this. Let’s change the world. Amgen is seeking a Material Compliance Associate at our Thousand Oaks, CA, campus. In this vital role, you will be responsible for assisting the Brand Marketers build and monitor their projects through the Material Approval and Compliance (MAC) review process. The MCA will quality check files submitted for review, collect “live” edits during compliance review and approval meetings, and edit submission documents within the electronic review system, Veeva. They will ensure all materials submitted adhere to Amgen MAC Standards and FDA requirements throughout the process.

• Quality check submissions for review to ensure alignment with internal standards

• Work with agencies and internal staff, including training on next steps and advising on process standards

• Provide administrative support during review meetings, including gathering “live” edits on submission documents

• Assist with Label updates

• Periodically assist on a variety of MAC-related projects

• Run Veeva reports and communicate outputs to cross-functional partners

• Proofreading commercial and training materials produced by the Marketing teams

• Revise documents electronically

Other skills

• Actively listen to and capture comments from meeting stakeholders

• Anticipate edits and work proactively to suggest solutions

• Ability to champion collaboration, work effectively on cross-functional teams, and consistently deliver timely

• Strong oral and written communication skills; strong interpersonal skills; demonstrated time management and decision-making skills

• Critical thinking and problem-solving skills

• Quick learner, proactive, takes initiative

• Able to distinguish an accurate balance between strategic and tactical thinking

• Strong experience with Project Management tools, methodologies, and practices

• Proven ability to manage in a highly fluid, interactive, matrix environment

• Experience with Microsoft Office 365 (e.g. Word, Excel, Outlook, and PowerPoint), Adobe products (e.g. Adobe Photoshop, Illustrator, and Acrobat Pro), and Veeva PromoMats

• Authoritative command of complexity and ambiguity, ability to see the big picture, ability to collect, digest, and assemble information to enable relevant business analysis and influence decision-making

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Bachelor’s degree

Or

• Associates degree and 4 years of Marketing Communications Project Management / Copy-Editing experience

Or

• High school diploma, or GED, and 6 years of Marketing Communications Project Management / Copy-Editing experience

Preferred Qualifications:

• Project management experience in the Pharmaceutical, Biotechnology, Healthcare-related field or other regulated industries

• Experience in leading the creation of marketing materials from concept to commercialization

• Experience managing the approval process of marketing materials that are produced at high volumes.

• Copy-Editing experience including excellent typing and spelling skills

• Able to proofread materials using Adobe Acrobat Professional

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Title:

POSITION IS CONTINGENT UPON CONTRACT FUNDING

KBR has an opening for a Technical Professional – IT Information Assurance to join our team of qualified, diverse individuals onsite at NBVC Point Mugu, CA This position requires on site presence. Remote or Tele-Work is not available.
 

Roles and Responsibilities:

• Serves as an Information Systems Security Officer (ISSO) for Government information systems in support of a Program Management Activity (PMA).

• Performs extensive assessments of systems and networks within the networking environment or enclave and identify where those systems/networks deviate from acceptable configurations, enclave policy, or local policy; Candidate will achieve this through passive evaluations (compliance audits) and active evaluations (vulnerability assessments). 

• Establish strict program control processes to ensure mitigation of risks and supports obtaining certification and accreditation of systems; This includes process support, analysis support, coordination support, security certification test support, security documentation support, investigations, software research, hardware introduction and release, emerging technology research inspections and periodic audits.

• Assists in the implementation of the required government policy (i.e., RMF, NISPOM, JSIG) and makes recommendations on process tailoring. 

• Performs extensive analyses to validate established security requirements and to recommends additional security requirements and safeguards.

• Supports the formal Security Test and Evaluation (ST&E) required by each government accrediting authority through pre-test preparations, participation in the tests, analysis of the results, and preparation of required reports. 

• Periodically conducts a review of each system's audits and monitors corrective actions until all actions are closed.

Functional Job Description:

• Implement Risk Management Framework (RMF) in accordance with NIST SP 800, Joint Special Access Program Implementation Guide (JSIG).

• Participates in the development and maintenance of system security plans and contingency plans for all systems under their responsibility.

• Draft, maintain, Planned, System Security Checklists, Privacy Impact Assessments, POA&M, and Authority to Operate (ATO) artifacts.

• Develop Plan of Action and Milestones (POA&M) for identified vulnerabilities and ensure compliance through monthly / quarterly updates.

• Maintain inventory of all information Security System assigned.

• Develop a variety of Assessment & Authorization deliverables including; System Security Plan (SSP), Security Assessment Report (SAR), Contingency Plan (CP) and POA&M for review and approval for Authorization Official

• Monitor and conduct Security Control Assessment to ensure all controls meet security requirements as stipulated in the SSP, NIST SP 800-53, JSIG.

• Effectively communicate Technical Information to non-technical personnel

• Coordinate with Leadership across the organization to ensure timely compliance.

• Develop Waivers and exceptions for information system vulnerabilities.

Basic Qualifications:

• Master’s degree in computer and architecture information systems management or related field from an accredited college or university or equivalent experience is required. OR

• Twelve (12) or more years of combined experience performing duties as described. OR

• Bachelor’s degree and an additional four (4) years of relevant experience may be substituted for a master’s degree. OR

• Associate’s degree and an additional eight (8) years of relevant experience may be substituted for a Master’s Degree

• Two (2) years of experience with mid-sized client/server systems in systems analysis, software design, software development, and system administration is required.

• Experience with DoD M5205.07 Series, Risk Management Framework (RMF) and Joint SAP Implementation Guide (JSIG) requirements is required.

• Knowledge of quality assurance, quality control, and independent verification and validation techniques is required.

• Experience working independently and as part of a team in researching data, developing analytical techniques and methodologies is required.

• Experience with managing secure Information Systems (IS) and databases while implementing and maintaining cross-domain solutions is required.

• A current Information Assurance Manager (IAM) Level I certification in accordance with DoD 8570.01-M, or the ability to gain the IAM Level I certification within six months is required.

• Applicant selected may be subject to a government security investigation and must meet eligibility requirements for access to classified information.

• A current Secret Clearance is required.

Contract requirements regarding education and experience will prevail.

KBR is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, disability, sex, sexual orientation, gender identity or expression, age, national origin, veteran status, genetic information, union status and/or beliefs, or any other characteristic protected by federal, state, or local law.

Business Unit:

Company Details:

Job Details:

Job Summary: The role has the dual responsibility to support the Government Compliance and Cost Accounting reporting requirements of the business. This position provides complex financial information and support to the operating unit’s management. The position also interfaces with government agencies such as DCAA and DCMA. Provides support for government audits and assists with maintaining compliance with government requirements including the Federal Acquisition Regulation (FAR) and Cost Accounting Standards (CAS). This position typically works under general supervision and direction. Incumbents of this position will regularly exercise discretionary and substantial decision-making authority

Essential Job Duties and Responsibilities:

* Participates in monthly accounting cycle

* Calculates monthly revenues and profits for subsidiary based on program performance

* Analyzes bookings and backlog based on contractual agreements

* Accurately reports status of actuals against plan and advises management regarding significant overruns

* Coordinates project plans with the Program Financial Operations (PFO) department and consolidates information by product line.

* Preparation of the annual Incurred Cost Proposals

* Updates Disclosure Statements

* Performs internal timekeeping audits

* Supports DCAA and DCMA audits

* Assists all levels of management in the determination of any policy changes that affect the financial performance of the operating unit

* Hybrid position with 3 days in-office weekly. #LI-hybrid

Minimum Job Requirements:

Four-year college degree in accounting, or equivalent, plus a minimum of four years related experience. Experience with DCAA/DCMA audit and government compliance. Must communicate effectively, both verbally and in written form, with all levels of employees including upper management. Must be competent with personal computer and be familiar with spreadsheet software (e.g., Lotus 1-2-3, EXCEL) and other Microsoft Office software. Ability to follow written and verbal directions. Ability to prioritize, complete multiple tasks, and work under deadlines. Able to concentrate, focus, and perform analyses. Adept analytic and numeric skills required. Must be able to work at a computer for extended periods of time.

The description provided above is not intended to be an exhaustive list of all job duties, responsibilities and requirements. Duties, responsibilities and requirements may change over time and according to business need.

Cubic Pay Range San Diego only:

$75,000-110,477 + benefits.

The Cubic pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

Worker Type:

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

DIRECTOR, CLINICAL QUALITY THERAPEUTIC AREA LEAD

Live

What you will do

Job Description

Let’s do this! Let’s change the world! In this vital role you will report to the Associate Vice President, Clinical & Research Quality (CRQ) and be responsible for a team of 5-10 colleagues. The Director, Clinical Quality Therapeutic Area Lead provides proactive end to end quality oversight strategies for the development and implementation of a customized risk-based quality assurance strategy for the clinical development program.

Director, Clinical Quality Therapeutic Area Lead will manage end to end Quality Oversight within one of three Therapeutic Areas (TAs): Oncology/Biosimilars, Immunology & Rare Diseases, and General Medicine. The TA Lead is responsible for implementing a risk-based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals).

You will be a vital role who develops deep knowledge of the TA’s clinical trials and provides oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.

Responsibilities

• Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes
• Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights
• Provide oversight for the development and implementation of Quality Plans
• Establish Regional expertise to ensure quality and compliance to local regulations
• Support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)
• Develop TA-specific Quality Assurance plans that are risk based and efficient. This includes TA specific audit plans, and the execution of audits (investigator site audits, affiliate audits, and study level audits)
• Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness activities, and Inspection Management, and Serious Breaches/ Privacy Issues
• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods)

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications:

Basic Qualifications:

Doctorate degree and 4 years of Quality Management, Quality Assurance, or other relevant experience

Or

Master’s degree and 8 years of Quality Management, Quality Assurance, or other relevant experience

Or

Bachelor’s degree and 10 years of Quality Management, Quality Assurance, or other relevant experience

In addition to meeting at least one of the above requirements, you must have a minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• 5 years of managerial experience directly leading people in a multi-tiered organization and an ability to build a high performing team.
• 5 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.
• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise. (including oversight of CAPAs, deviations, etc.)
• Thorough understanding and deep knowledge of Clinical Development activities / Clinical Trials and Global Regulations.
• Knowledge of the Regulatory Submission and Inspection Management procedures.
• Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.
• Excellent verbal and written communication skills, including strong business writing abilities and active listening.
• Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format.
• Strong analytical, critical-thinking, and decision-making abilities.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range