Supervisor, Quality Control Environmental Monitoring and Sterility Assurance

Catalent Pharma Solutions Inc   •  

Madison, WI

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 194 days ago

This job is no longer available.

  • Position Summary

    Catalent is looking to recruit a Supervisor, Quality Control Environmental Monitoring and Sterility Assurance to join a growing team in Madison, WI. The Supervisor, Quality Control Environmental Monitoring and Sterility Assurance will work to assure that operations at Catalent meet client requirements and cGMP regulations via Quality Control staff. The position is expected to possess a thorough understanding of laboratory procedures and cGMP testing and can conduct work within cGMP guidelines.

    The Supervisor, Quality Control Environmental Monitoring and Sterility Assurance assures the coordination of resources and work schedules for laboratory activities and will understand environmental monitoring schedules on the operations floor. In addition, the Supervisor is responsible for managing all aspects of sterility assurance including environmental and personnel monitoring teams ensuring compliance within the facility. This position will interact with other departments in support customer programs and overall projects assigned to environmental monitoring team.

    At Catalent, Patient First Philosophy is the blueprint that builds on that commitment and sets the framework to put people and patients first by improving their health outcomes. Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.

    The Role

    • Supervises all environmental and personnel monitoring (EM/PM) staff providing learning and development where appropriate.
    • Oversees daily assignment and operations to support microbiological product in-process and release testing, raw material testing, as applicable.
    • Oversees the Environmental Monitoring (EM) program in support of the manufacturing facility.
    • Authors and reviews trend analysis of environmental monitoring data including quarterly and annual trend reports.
    • Reviews departmental documentation (e.g., Standard Operating Procedures, deviation and CAPAs).
    • Collaborates significantly with cross functional groups, including QC Analytical, QA, Manufacturing, Process Development, and Regulatory Affairs.

    The Candidate

    • PhD in Microbiology, or related field, with no prior experience; or
    • M.S./M.A. in Microbiology, or related field, with minimum of 4 years’ experience in related laboratory work; or
    • B.S./B.A. in Microbiology, or related field, with minimum of 7 years’ experience in related laboratory work.
    • 7+ years of relevant work experience in a current Good Manufacturing Practices (cGMP) environment with progressive responsibilities

    Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

    • Leads with Integrity and Respect
    • Delivers Results
    • Demonstrates Business Acumen
    • Fosters Collaboration and Teamwork
    • Champions Change
    • Engages and Inspires
    • Coaches and Develops

    Position Benefits

    • Potential for career growth within an expanding team
    • Defined career path and annual performance review & feedback process
    • Cross functional exposure to other areas of Catalent
    • Medical, Dental, Vision, and 401K are all offered from day one of employment
    • 19 days of paid time off annually + 7 paid holidays

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