QA / QC Specialist – Pharmaceutical Key Responsibilities : Perform in-process and finished product testing as per pharmacopeia and SOPs. Review batch manufacturing and packing records to ensure cGMP compliance. Develop, review, and implement SOPs, validation protocols, and quality procedures. Conduct quality checks on raw materials, intermediates, and stability samples. Ensure compliance with cGMP, FDA, EMA, MHRA, and WHO regulatory guidelines. Handle deviations, CAPA, OOS / OOT investigations, and maintain quality documentation. Support regulatory and customer audits; prepare responses and ensure audit readiness. Coordinate between Production, QC, and QA for timely product release. Qualifications & Skills : Bachelor’s / Master’s in Pharmacy, Chemistry, or related field. 5+ years’ experience in QA / QC within pharma / biopharma manufacturing. Strong knowledge of analytical techniques (HPLC, GC, UV) and documentation practices. Good understanding of cGMP, ICH, and regulatory compliance. Excellent problem-solving, documentation, and cross-team coordination skills.
Specialist • Tampa, FL, United States