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GMP QC Manager

  • Job type: Permanent
  • Location: Watertown, Massachusetts
  • Salary: Negotiable
  • Job reference: 316621/003_1559685151
  • Sector: Quality Control, EPM Scientific
  • Date posted: 04/06/2019

Quality Control Manager

Watertown, MA

Full-time, onsite, permanent

A biopharmaceutical company that specializes in ophthalmic products is looking to bring on a QC Manager to their Quality team.

This role would be responsible for managing the GMP QC laboratory and ensuring all products are tested for both analytical and microbiological assays.

The role is responsible for overseeing:

  • Testing of raw materials and final products by following analytical methods

  • Sample management and incoming quality assurance (IQA) verification of raw materials

  • Operation and maintenance of instruments of all analytical assays

  • Investigations regarding out-of-trend (OOT)/out-of-specification (OOS) results, or Environmental Alert/Action Report (EAR).

  • Deviations related to analytical/microbiological procedures

  • Reviewal of SOPs, Specifications, Qualification/Validation protocols and reports

Ideal candidate looks like:

  • BS/BA or MS degree

  • 7-10 years of Quality Control experience in GMP regulated laboratory

  • Working knowledge of High Performance Liquid Chromatography (HPLC) and Spectroscopy

  • Familiarity with Gas Chromatography (GC) or Thin Layer Chromatography (TLC), considered a plus

  • Working knowledge of Environmental Monitoring (EM) and other microbiological assays such as: endotoxin, bioburden, sterility, etc.

  • Expertise of GMP documentation and application of principles, theories and practices of the analytical chemistry and/or microbiology

Apply now if interested!

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