Quality Control Manager

3 weeks ago


Harmans, Maryland, United States Catalent Inc Full time
About the Role

The Manager, QC Program Management is responsible for providing strategic support and oversight to the QC Client Services Team as they support the Quality Control and Batch Disposition departments, ensuring samples are tested on time and QC deliverables are met as part of client's analytical implementation.

Key Responsibilities
  • Manage the OTL for analytical method implementation and support SMPs and Batch records implementation review.
  • Attend client meetings to establish testing and stability protocols.
  • Ensure completion of project team assigned QC related activities.
  • Coordinate internal testing with Quality Control group.
  • Coordinate product and raw material testing with external testing laboratories.
  • Coordinate with the stability group and clients to establish stability studies.
  • Review and approve client sampling plans.
  • Review and approve batch records. Ensure sample testing schedule is accurate.
  • Develop and maintain QC client activities tracker.
  • Communicate manufacturing and testing schedules to the Quality Control group.
  • Effectively communicates with clients on QC related items/results.
Requirements
  • Masters' degree in a Scientific, Engineering or Biotech field with 6 – 8 years' experience Quality Assurance/Quality Control function reviewing Analytical testing data for analytical assays such as ELISA, DDPCR, HPLC, SDS-PAGE, Western blot OR as an Analytical Chemist with documentation review.
  • Bachelor's degree in a Scientific, Engineering or Biotech field with years' experience Quality Assurance/Quality Control function reviewing Analytical testing data for analytical assays such as ELISA, DDPCR, HPLC, SDS-PAGE, Western blot OR as an Analytical Chemist with documentation review.
  • Strong communication skills.
  • Proficient in Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines.
  • Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
  • Exposure to Lean Operational Excellence highly desirable.
What We Offer
  • Competitive medical benefits and 401K.
  • 152 hours PTO + 8 Paid Holidays.
  • Dynamic, fast-paced work environment.
  • Catalent offers rewarding opportunities to further your career.
  • Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
Why Catalent?

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.



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