Job Summary

Responsibilities

•     Responsible for ensuring compliance with relevant Standard Operating Procedures, while gathering, analyzing and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation and complaint has on the product, process, and patient health and safety.        

• As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on previously manufactured product, as well as the risk to future operations.

• Prepares and analyzes manufacturing and laboratory analytical historical data and uses methodical root-cause analysis tools to determine root causes and effectively communicates the root cause to senior management.     

• The incumbent will need to properly assess the manufacturing or analytical environment, independently conceive, and advise senior management on appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using industry accepted analytical tools.     

• The individual in the position provides technical expertise to the site to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely.    

• Updates and maintains all related enterprise quality management systems in compliance with various governing procedures and policies as they relate to investigations and performs trend analysis.     

• Works independently to comply with procedure driven guidelines relating to Deviation and complaint investigations and makes decisions that directly affect patient health and safety.     

• Demonstrates strong technical skills; provides technical assistance to area supervisors, managers, and technical writers to solve complex problems.

• Ensures that deadlines are maintained and closely monitors the need for extensions to be administered in relation to Subsequent Actions and Investigations in order to maintain compliance in this area.   

• Accountable for commitments agreed upon with department management. Required to comply with closure targets and provide adequate justification if commitments are not met.   

• All employees are responsible for ensuring the compliance to company documents, programs and activities related to Health, Safety, Environment, Energy and Quality Management System as per your roles and responsibilities.  

• Any other task as directed or requested by management or site leadership.

REQUIREMENTS

•     BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience

•     3 - 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices.

•     Good deductive and inductive critical thinking skills required.

•     Advanced technical writing skills required.

•     Candidate must possess strong interpersonal, written, and verbal communication skills.  Incumbent must be able to interface positively with Regulatory Agencies, vendors, and company departments.  Good knowledge of MS Office programs, including Word and Excel.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Title:

KBR Government Solutions delivers full life cycle professional and technical solutions that improve operational readiness and drive innovation. Our solutions help ensure mission success on land, air, sea, space and cyberspace for the Department of Defense, intelligence community, NASA, and other federal agencies. KBR’s areas of expertise include engineering, logistics, operations, science, program management, mission IT and cybersecurity.

Join our dynamic Government Solutions Business Development team and contribute to our mission of growth and excellence. Our small, robust team is a dynamic and tightly knit group of professionals dedicated to achieving excellence in our work. We take pride in our ability to make a significant impact within our organization, and we're looking for individuals who are eager to contribute and grow with us.

This is a REMOTE / Work from Home position. Occasional travel may be required. Must be located within the continental United States.

As a Proposal Writer, you will:

• Play a pivotal role in crafting compelling narratives that showcase our company's capabilities, expertise, and successes.
• Write, edit, and produce persuasive strategic content for proposals, corporate databases, sales documents, and other business development-related projects.
• Identify and gather relevant information sources to enrich proposal content, including conducting interviews and research as needed.
• Support initiatives to organize and upload content within corporate databases and archives.
• Work closely with stakeholders, including Subject Matter Experts, to capture concepts, maintain messaging consistency, and ensure alignment with our corporate strategy.
• Proofread and edit your own work and the work of others, ensuring it aligns with in-house and client styles.
• Coordinate multiple simultaneous proposals, create outlines and storyboards to guide content development, and manage proposal plans.
• Collaborate with graphic designers to develop visuals that enhance narrative content.

REQUIREMENTS

• Must have a Bachelor's degree (BA/BS), preferably in English, Journalism, or a relevant field plus a minimum of 2 years of relevant experience, additional related professional experience may be considered in lieu of a degree.
• Requires exceptional persuasive writing skills with the ability to tell a clear and compelling story.
• Must be detail-oriented, with excellent time management skills to thrive in a deadline-driven environment.
• Requires proficiency in Microsoft Office products.
• Must have strong interpersonal skills, ability to build rapport, and work effectively in a team.
• Must be flexible and able to adapt to changing priorities and occasional overtime requirements (including over weekends and holidays, potentially on short notice).
• Requires a commitment to KBR's mission and values.

Preferred Qualifications:

• Familiarity with SharePoint and Adobe Creative Suite.
• Previous KBR or related federal contractor / industry experience.

INCLUSION AND DIVERSITY AT KBR

At KBR, we are passionate about our people, sustainability, and our Zero Harm culture.

These inform all that we do and are at the heart of our commitment to and ongoing journey toward being a more inclusive and diverse company. That commitment is central to our team of teams philosophy and fosters an environment of real collaboration across cultures and locations. Our individual differences and perspectives bring enhanced value to our teams and help us develop solutions for the most challenging problems. We understand that by embracing those differences and working together, we are more innovative, more resilient, and safer.

We Deliver – Together.

KBR EQUAL OPPORTUNITY EMPLOYER STATEMENT

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.

#LI-KBRJN

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.