Senior Specialist, QA (Mfg Support)

Full-time Other-General

The QA Specialist provides Quality Assurance oversight for manufacturing activities within a large‑scale, multi‑product GMP biopharmaceutical contract manufacturing facility, ensuring compliance with regulatory and internal quality standards.

Responsibilities

• Provide daily QA support in line with established SOPs, policies, and GxP standards.
• Review and approve SOPs, protocols, reports, batch records, and other quality‑related documents.
• Evaluate batch records and logbooks, assist with changeovers, and compile lot genealogy to support batch disposition activities.
• Participate in or lead deviation investigations, change controls, CAPA processes, and closure of discrepancy reports.
• Identify and resolve quality and operational issues, recommending effective corrective actions.
• Manage small‑scale projects and ensure timely delivery of assigned tasks.
• Foster strong relationships with both internal teams and external...