Total 3 Senior Executive level Quality Assurance / Control job vacancies in Co. Cork, P17 NY71

What Quality Assurance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Responsibilities

• Quality Assurance responsibilities include, but are not limited to, cGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production and process controls.
• Establish and report metrics related products and processes.
• Establish and maintain quality control procedures.
• Assist in determining types of tests to be performed as well as documentation and reporting requirements.
• Champion Quality, cGMP compliance, and EHS/Radiation Safety practices.
• Actively partner with plant management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems.
• Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements.
• Ability to network across business and functional units to achieve positive outcomes.
• Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting. In that context, has the knowledge of the production process of the product.
• Understands technical/release product issues and evaluates their potential impact on product quality and compliance.
• Provides ideas for continuous improvement of the cGMP Quality Management System.
• Escalates complex issues to management in a timely manner.
• Prioritizes and ensures work is delivered in an efficient way.
• Performs other job duties as assigned.

Qualifications

• Bachelor’s of Science preferred – Chemistry degree highly preferred or equivalent work experience preferred
• 2+ years’ experience in a regulated environment preferred, pharmaceutical experience preferred.
• Possess an understanding of cGMP/compliance requirements for 210/211 preferred.
• Strong attention to detail.
• Ability to manage timelines and priorities.
• Ability to work independently with minimum guidance.
• Ability to multi-task.

Schedule

• Onsite in Aurora, CO. Typically, Monday-Friday between 8:00 am-5:00 pm. Candidate must be available to work weekends to provide coverage at site. Weekend work will be limited.

Physical/ Mental Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; balance; stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 25 pounds.

Work Environment

• The primary work environment consists of an office, warehouse, and production environments within a radiopharmaceutical manufacturing facility. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards.  The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory groups. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

What is expected of you and others at this level

• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
• Works on projects of moderate scope and complexity
• Identifies possible solutions to a variety of technical problems and takes action to resolve
• Applies judgment within defined parameters
• Receives general guidance and may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

Anticipated salary range: $74,500-$106,400

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 05/11/2024 *if interested in opportunity, please submit application as soon as possible.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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Senior Quality Project Engineer

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

Alcon is the global leader in eye care, dedicated to helping people see brilliantly. With our 70-plus-year heritage, we are the largest eye-care device company in the world – with complementary businesses in Surgical and Vision Care. Being a truly global company, we work in over 70 countries and serve patients in more than 140 countries.

We are currently recruiting for a Senior Quality Project Engineer to join our team here in Cork. You research process technologies and process control improvements for site implementation. They apply comprehensive and diverse knowledge of engineering principles and practices for Quality focused process controls improvements. They use specialist knowledge and leadership in leading the execution of these improvement activities. A typical day in this role will include;

• Utilize Quality Engineering principles and problem-solving skills to improve and maintain processes that are aligned with the overall Quality and Business vision while ensuring production build schedule attainment.
• Responsible for introducing and validating new process control projects from design through completion and in compliance with regulatory requirements.
• Work with automation solution providers to specify, design and implement solutions if necessary. Responsible for supporting and improving existing process controls through process analysis and the application of engineering principles.
• Employ appropriate risk management to prevent unanticipated failure modes.
• Ensures effective quality strategies are created for the validation of equipment, test methods and processes as well as risk management documentation in accordance with regulatory requirements and internal Alcon requirements.
• Responsible for project management & planning and for liaising with other departments/plants affected by these projects. Also for reporting project status to management and highlighting areas of concern early. Responsible for ensuring all projects are completed to agreed timelines and within budget. Also that all work adheres to H&S and environmental requirements.
• Author/Reviews Test Methods, Specifications, Validation Protocols, Deviations, Investigations, Impact Assessments and other forms of Quality documentation as assigned.
• Perform an active role in further development of the quality management system and drive continuous improvement and innovation from a quality perspective.
• Actively participate in external audits by Notified Bodies and Health Authorities as subject matter expert for areas of responsibility.

What You Will Bring To Alcon:

• Third level qualification in a Business or Engineering Discipline
• As minimum 5-10 years in a medical device or pharmaceutical environment
• Preferred 5 years’ experience in Medical Device or Pharmaceutical industry with a Bachelors degree in a technical discipline
• Knowledge of FDA, medical device, GMP and validation requirements.
• Experience in Equipment and process validations.
• Excellent Project management problem solving & analytical ability.
• Attention to detail with excellent organizational skills.
• Knowledge of Line Clearance and Product Segregation requirements Report writing expertise and highly developed people skills.                                      

How You Can Thrive At Alcon

• A competitive salary package with fixed salary, bonus, pension and health insurance
• A flexible work environment with competent and committed colleagues. We enjoy working together in a good and respectful manner, and we celebrate our common successes
• See your career like never before with focused growth and development opportunities                                 

Alcon Careers

See your impact at www.alcon.com/careers

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What Quality Assurance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring. 

Responsibilities

• Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
• Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager RQM.
• Ensures the site manufactures products to meet the requirements of 21 CFR 212 (CGMP).
• Handles and ensures quality of documentation (control, retention, and archival) to support CGMP activities.
• Engages and collaborates with operations department to drive quality system and CGMP requirements.
• Performs product release activities per CGMP requirements.
• Monitors CAPA in investigations and closes when completed or escalates (if necessary).
• Performs aseptic review of the site with operations and documents results.
• Reports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identification.

Schedule:  Onsite in Denver, CO. 40 hours per week.  This is a night position.  Typically, Monday - Friday 1:30 am – 10:00 am.  Candidate must be flexible to work different shifts or schedules based on business need. Candidate must be comfortable staying until work is completed each business day.  Work hours may be subject to change.

Qualifications

• Bachelor’s degree in related science field, or equivalent work experience (Microbiology, Chemistry, Biology, Physics) preferred
• 2+ years of experience in related science field preferred
• 1-2 years of experience in Quality Assurance and/or regulated environment highly preferred – cGMP
• Pharmaceutical or medical device experience a plus
• Effective written and verbal English communication skills
• ISO experience a plus
• Ability to lift between 30-45 lbs.
• Proficiency with SAP, Microsoft Excel, Microsoft Word, Microsoft Outlook, and Microsoft Power Point.
• Understanding of the requirements and can perform gap assessments to those requirements, a plus
• Ability to analyze and interpret results from chromatograms by HPLC, Gas Chromatography, and E-Z Scan radiometric TLC scanner, a plus
• Understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving, a plus

The primary work environment consists of a manufacturing pharmacy which must be kept clean, orderly, properly lighted and maintained in optimum operating condition. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

What is expected of you and others at this level

• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
• Works on projects of moderate scope and complexity
• Identifies possible solutions to a variety of technical problems and takes action to resolve
• Applies judgment within defined parameters
• Receives general guidance and may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

Anticipated salary range: $74,500-$106,400

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 04/08/2024 *if interested in opportunity, please submit application as soon as possible.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

To read and review this privacy notice click here