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QA Manager

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Buffalo, NY
$90,000 - $110,000
Job Type
Direct Hire
Bachelor of Science
Sep 07, 2017
Job ID

Provides quality oversight to the Chemistry & microbiology laboratories and product transfer by supporting all work. Work in partnership with the aforementioned groups to produce quality work in compliance with all applicable regulations. 

- Review/approve deviations, OOS's, OOT's, EE's, and change controls.
- Perform audits of the chem & micro labs.
- Review/approve protocols, investigative studies, raw data and reports. 
- Establish and control quality programs to ensure conformance and compliance to company policies and regulatory standards. 
- Leads, manages, and participates in quality projects and teams to implement improvements to the processes, facilities, and equipment quality system infrastructure to meet regulatory requirements. 

- Minimum BS and 10+ years experience in pharma or biotech industry. 
- Knowledge of GxP's for testing and release of pharmaceutical products.
- Experience with equipment qualification and calibration.
- Experience in analytical techniques and validation of methods. 
- Prefer experience with aseptic processing.