Specialist QA – Quality Assurance

About the role

Under minimal supervision, the Specialist QA performs a wide range of quality‑assurance activities to ensure compliance across manufacturing, facilities, utilities, environmental programs, and quality systems. The role reviews and approves critical GMP documentation, leads investigations, supports audits, and provides lot disposition for product release.

Key responsibilities

• Review and approve product master records, process validation protocols, and environmental characterization reports.
• Approve work orders, EMS/BMS alarms, non‑conformance investigations, CAPA records, and change controls.
• Provide lot disposition, authorize shipments, and maintain site quality program procedures.
• Lead investigations, ensure timely closure, and conduct site audits supporting internal and external inspections.
• Evaluate compliance issues using advanced data trending and serve as QA designee on local change‑control review boards.
• Represent QA on New Product Introduction teams and collaborate with manufacturing, validation, quality control, engineering, facilities, utilities, and contractors.

Required profile

• Doctorate, or Master’s + 2 years, or Bachelor’s + 4 years, or Associate’s + 8 years, or High School/GED + 10 years of directly related experience.
• Experience performing on‑the‑floor Plant Quality Assurance activities, including review, approval, and tracking of cGMP processes, procedures, testing methods, batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise.

Required skills

• cGMP process knowledge and documentation review.
• MES/EBR, SAP, EDMQ, DQMS, TrackWise.
• Deviations, CAPA, change control, and validation activities.
• Computer‑systems validation and GxP application validation (VMP, IQ, OQ, PQ, test scripts, summary reports).

What we offer

• Non‑standard shift schedule.
• 6‑month fixed‑term contract with possible extension.