MQA Specialist I

Job Summary Position is responsible for quality oversight and assistance to production processes, supporting departments and laboratories. Position recommends corrective action in responsible to deviations noted. Assures compliance to SOP’s and cGMP’s. Maintains the finished product reserve appropriate sampling and FDA retention sample storage areas.

Responsibilities Drive a culture of continuous quality improvement by on the shop-floor presence

Act with competency, integrity and appropriately as Quality Assurance personnel and assure that the processes required are adhered to Authorized to stop production activities and contain materials and/or products with immediate effect where Critical Deviations are noted

Escalate Isolated and Systemic issue to site management, including proposed CAPAsMQA shop-floor activities must cover the entire production and support processes which, depending upon the plant’s business operations will include but not limited to:

Weighing and Dispensing verification

Bulk Solution Preparation Component Preparation identification and verification

Monitoring of In-Process Controls Oversight of Filling/Lyophilization activities (including completion of Aseptic Gowning Qualification)
Finishing Activities, including Integrity Testing Verification, adherence of general inspection requirements/timelines, execution of sampling plan Performance of Visual Inspection (AQL)
Packaging oversight

Warehousing/Storage requirement adherence

Monitoring of Facilities and Utilities per required parameters QA key contact to shop floor employees

On the floor QA contact to escalate issues and provide real-time documentation requirements/trouble shooting analysis

Participate in 5S activities

Support in investigations & root-cause analyses (incidents & investigations)
Shop-floor documentation review of MBRs and logbooks for GMP and procedural compliance

Support quality and compliance and continuous Improvement projects

Special oversight activities based on case by case demand to include but not limited to:media fillsrepackagingreworkingvalidation/investigation study activities other duties as assigned

Salary Range: $60,966-$85,694

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

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.
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