Job Description

The QC Lab Manager manages and coordinates cGMP laboratory activities for an aseptic filling CMO; Supporting Medical Device and Pharmaceutical product platforms.

Personnel management, project management, analytical method development, and validation.

Responsible for the development, optimization, trouble-shooting and technical transfer of routine and non-routine chemical and microbial assays and formulation transfers, and will support process qualification.

Works independently and collectively as part of an integrated team environment with extensive interactions with Manufacturing, Maintenance, QA, and Administrative departments.

Responsible for OOS investigations, ENCAR Reports, and product MRB disposition in coordination with the QRT Team. The QC Lab Manager will report directly to the General Manager.

BS Degree in Chemistry, Biology or Life Science

5+ years experience in Management of a Quality Control Laboratory

Experience with ISO, GMP, Medical Device, Pharmaceutical Manufacturing and Aseptic Filling

Application Instructions

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