Assistant Manager, QA (Hoschton, GA)
Pay Rate: $95,000
Location: Hoschton, GA
Schedule: 7:30 AM to 4 PM
Job Summary
As a Sr. Chemist, lead quality assurance of in-process controls, document control, and labeling control of pharmaceutical products in compliance with ANDA and Audit, applying Regulatory audit process; Lead IPQA activities using QMS, Hold Time Study Protocol / Report; Review and conduct QA checks of master batch records within the pharmaceutical manufacturing process; Ensure compliance with quality standards for the testing of pharmaceutical raw ingredients and in-process and finished products; Lead in the maintenance and implementation of SOP system for the entire quality unit; Ensure OOS and OOT results are thoroughly investigated, root cause identified, and appropriate corrective actions implemented; Lead in inspection readiness system in compliance with local, state, and federal regulations and guidelines, including FDA, FMEA, EMA, EPA, DEA, and OSHA; Coordinate and facilitate internal and external audits; Review and approve validation protocols and reports, including Process Validation, Equipment & Facility Validation; Maintain pharmaceutical stability program, maintain stability schedule, and investigate failure. Supervise 2 chemists.
The ideal candidate has:
- Master’s Degree in Chemistry or Pharmaceutical Science plus 2 years experience in job offered.
- Skills and knowledge in ANDA, Regulatory Audit, QMS, Process Validation, Equipment & Facility Validation, IPQA, Hold Time Study Protocol/Report, FMEA, Master Batch Records.
To apply, please submit résumé referencing job code MAC004 to HR hr@aavispharma.com, Aavis Pharmaceuticals, 9488 Jackson Trail Road, Hoschton, GA 30548.
