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Posted: Wednesday, October 4, 2017 8:10 PM

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. EDUCATION & EXPERIENCE: - 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. PI99754497


• Location: Buffalo

• Post ID: 31808057 buffalo is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017