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QC Manager
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- Job DescriptionJob DescriptionSr. Manager Quality ControlXseer Pharmaceuticals, an FDA licensed outsourcing pharmaceutical 503B is seeking a full-time on-site QC Sr. Manager for our manufacturing facility located in Los Angeles, CA. The QC Manager will be responsible for developing and managing the QC staff and systems and overseeing all QC activities to ensure compliance with industry standards and regulations.
- Build GMP quality systems and the compliance infrastructure for the Quality Control labs.
- Establish and maintain analytical assay performance trending program and reference standard trending program.
- Lead inspections by FDA, or other regulatory agencies for Quality Control topicsResponsible for analytical testing for incoming raw materials and product releaseResponsible for use of laboratory/analytical equipmentResponsible for Environmental Monitoring programResponsible for compounding operator training content and respective complianceTrains operators in aseptic processing from gowning and entry to critical steps involving aseptic filling, crimping, lyophilization load/unload, and more.
- Have strong understanding of cGMP as it pertains to a sterile injectable drug manufacturing facility.
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