QC Supervisor


Fremont, CA

What you'll be doing

The QC supervisor is responsible for leading the shift teams to support testing during manufacturing. Oversees and performs the assigned task/sample analyses, ensuring the quality and timely delivery of the test and study results. The supervisor writes and reviews study protocols, reports, SOPs and other assigned documents, and is familiar with method validation and spreadsheet validation. Perform and support internal and external quality audits when needed. Perform lab investigation, OOS and OOT investigations. Prepare deviation report and CAPA, as needed. Lead, supervise, mentor and provide technical support to QC analysts. Ensure quality system requirements are followed and maintained and all team personnel comply with cGMP requirement.

What your background should be

Advanced knowledge of HPLC and familiarity with Empower software are required. Knowledge of analytical techniques, such as GC, FTIR, UV, KF, are preferred. Experience on reviewing microbiological and endotoxin data are preferred. Ability to work independently and as part of a team; ability to motivate self and others. Good written and communication skills. Ability to take initiative and prioritize tasks; good time-management, problem-prevention; and problem-solving skills. Ability to manage multiple functions.

Required Schooling / Training

Not specified

Who is the client company

Formerly named The Macroflux Corporation, is a specialty pharmaceutical company.
If you are interested in this position, send your resume to apply@kochdavis.com