Job Description

Responsible for quality assurance activities/decision making associated with cGMP manufacturing, investigations, change control, complaint investigations and documentation. Ensures that proper controls are instituted and maintained during the manufacturing, processing, packaging and warehousing of in-process and finished product. The position will take direction and report to the Manager MQA.

Salary Range: $60,955-$85,694

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

• The Specialist performs some or all of the following accountabilities as assigned:
• Defining and specifying activities, processes, and standards to fulfill the quality requirements for a manufactured material, component, or product
• Building and maintaining the infrastructure and systems necessary to consistently ensure the timely delivery of quality products
• Auditing, monitoring, and determining the quality of manufacturing processes and/or outputs against defined internal and regulatory standards
• Reporting and troubleshooting manufacturing process deviations and defects in finished goods
• Ensure compliance to all requirements established for product manufactured and the systems supporting manufacturing.
• Assist with internal, corporate, 3rd party and federal/state audits.
• Advise and assist in the disposition of restricted material. Actively participate in the Material Review Board (MRB).
• Lead problem identification and resolution efforts for quality related issues from the manufacturing operations.
• Investigate issues, define and direct implementation of solutions.
• Review and approve SOPs and other documentation.
• Monitor operations to ensure that the necessary resources are provided to allow timely release of final product.
• Represent QA for Media Fill execution.
• Compile and/or review data for annual product reviews as assigned.
• Generate all cGMP documentation associated with work activities.
• Maintain assigned standard operating procedures.
• Performs other related duties as assigned.

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 contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

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.