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Quality Assurance Manager

4 months ago

Kalamazoo, United States Medix™ Full time

Medix is currently hiring for a dynamic Quality Assurance Manager to join a pharmaceutical manufacturing team that we partner with in the Kalamazoo, MI area. If you have a background in Quality Assurance supporting pharmaceutical production, consider applying today


PURPOSE:

The Quality Assurance Manager will be responsible for defining the Quality Management Systems and ensuring that manufacturing and QC activities for the production and testing of active pharmaceutical ingredients for human use are consistent with applicable GMP regulations and company policies.


DUTIES AND RESPONSIBILITIES:

  1. Assists in hosting all regulatory inspections and customer audits
  2. Approves all analytical methods and stability protocols
  3. Approves all specifications and master production instructions
  4. Reviews and approves completed batch and laboratory control records before release of the API/product for distribution
  5. Signs CoAs along with QC
  6. Releases or rejects all APIs/raw materials/products
  7. Collaborates with relevant departments to ensure that deviations are investigated and completed in a timely manner; elevates all critical or major investigations to the attention of the QU Manager
  8. Collaborates with relevant departments to review and approve change controls; as well as ensure change controls are completed in their respective time frames
  9. Approves suppliers of raw materials to be used in manufacturing and assists in audits of suppliers as needed
  10. Approves intermediate and API contract manufacturers
  11. Assists in performing internal audits (self-inspections)
  12. Reviews and approves validation protocols and reports
  13. Ensures that effective systems are used for maintaining and calibrating critical equipment
  14. Ensures that materials are properly tested and the results are reported
  15. Manages the GMP training program, develops training exams, schedules and leads GMP training activities


MINIMUM QUALIFICATIONS, SKILLS, AND REQUIREMENTS:

  • Bachelor’s Degree in Analytical Chemistry or related field, advanced degree preferred.
  • 5 years experience in pharmaceutical quality assurance, with a demonstrated ability to deliver effective processes that are aligned with CGMP and EHS regulations and guidance, and with industry best practices.
  • Demonstrated experience with clinical CGMP requirements is required, commercial CGMP requirements is preferred
  • Demonstrated ability to manage diverse workflows and implement process and procedural improvements.
  • Demonstrated excellent written and oral communication skills