Quality Assurance Specialist
We are seeking an experienced Quality Assurance (QA) Specialist to provide hands‑on, real‑time QA support within a GMP‑regulated manufacturing environment. This role is focused on on‑floor quality oversight in classified manufacturing areas, ensuring compliance, data integrity and right‑first‑time execution of manufacturing operations.
The QA Specialist works closely with Manufacturing, Quality Control, Engineering and Facilities teams to support compliant production activities, identify and resolve quality issues, and maintain inspection‑ready documentation at all times. This is an onsite role requiring full gowning and regular presence in cleanroom and controlled areas.
Key Responsibilities
- Provide real‑time QA support for moderate‑complexity manufacturing operations within classified and cleanroom environments
- Maintain continuous on‑floor presence to support compliance, production activities and issue resolution
- Perform in‑process batch record review, ensuring accuracy, completeness and compliance with cGMP requirements
- Review manufacturing documentation, environmental monitoring data and related quality records
- Perform and verify line clearance activities for assigned manufacturing processes
- Identify, document and resolve standard quality issues; escalate higher‑risk or non‑routine issues as appropriate
- Support deviation investigations, CAPAs and remediation activities
- Review and approve facility alarms, work orders and return‑to‑service documentation
- Participate in audits, inspections and cross‑functional quality initiatives
- Comply with all gowning, safety and cleanroom behaviour requirements
About You
- Bachelor's degree in an applied science discipline or equivalent experience
- Minimum 5 years' experience in Quality Assurance within a GMP‑regulated manufacturing environment
- Aseptic or sterile manufacturing experience preferred
- Strong working knowledge of cGMP regulations and quality systems
- Sound judgement when assessing quality and compliance risks
- Excellent documentation, analytical and problem‑solving skills
- Confident communicator, able to collaborate effectively with cross‑functional teams
- Able to manage multiple priorities with limited supervision
Working Environment
- Full‑time onsite role within a GMP manufacturing facility
- Regular work in classified areas and cleanrooms, including full gowning
- Requires extended periods of standing and hands‑on presence on the manufacturing floor
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