Quality Assurance Specialist

About the role

The Quality Assurance Specialist provides on‑floor oversight and documentation review to ensure compliance with cGMP, internal procedures, and regulatory expectations. Working with cross‑functional teams, the specialist supports product quality, operational excellence, and continuous improvement across manufacturing sites.

Key responsibilities

• Review and approve product manufacturing procedures, validation protocols, and manufacturing reports.
• Perform Plant Quality Assurance (PQA) reviews, track batch records, MES/EBR, SAP, EDMQ, DQMS, Trackwise documentation, deviations, CAPAs, and validations.
• Lead incident triage, deviation initiation, and ensure procedural compliance.
• Approve environmental characterization reports, sanitary utility releases, and lot dispositions.
• Coordinate testing with contract laboratories, review external lab data, and support commissioning, qualification, and validation activities (IQ/OQ/PQ, Validation Master Plans, protocols, reports).
• Represent QA in New Product Introduction (NPI) activities and act as QA designee for CCRB.
• Maintain site quality program procedures, review risk assessments, and support automation, facilities, and engineering programs.

Required profile

• Doctorate, Master’s with 2 years, Bachelor’s with 4 years, Associate’s with 8 years, or High School/GED with 10 years of directly related experience.
• Experience in change control, documentation review, validation, and PPQ.
• Strong knowledge of manufacturing, distribution, QA, QAL, and process development processes.
• Proven ability to lead investigations, audits, and support internal/external inspections.

Required skills

• cGMP compliance
• SAP
• MES/EBR
• EDMQ
• DQMS
• Trackwise
• Computer systems validation
• GxP application validation
• Change Control
• PPQ (Process Performance Qualification)