Job Description

Quality Assurance Specialist

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

Principal Activities Performed by the Incumbent

• 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 CAPAs
• MQA 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 fills
  • repackaging
  • reworking
  • validation/investigation study activities
  • other duties as assigned

Requirements

• Minimum of High School Diploma with one (1) to three (3) years of work experience required
  • Associate degree or High School diploma with previous related field experience or knowledge of a GMP regulated industry preferred
• Candidates must have knowledge of the competencies as described below and complete the required training activities in the defined timelines:
  • Knowledge & expertise in regulatory requirements and industry / company best practices approaches
  • Competency in different computerized system (including software)
    • Knowledge of Word/Access and Excel applications is a plus
  • Aptitude for understanding of the technology employed in production activities
  • Organizational abilities, troubleshooting capabilities, stress resilience, personal integrity
  • Relevant work experience/functions (production activities)

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.

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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