A global life sciences organization is seeking a hands-on QA Officer to support manufacturing operations at a production site. This operational Quality Assurance position focuses primarily on GMP label control, label issuance and reconciliation, alongside operational and Aseptic Processing (AP/APS) batch record review. In this role, you will work closely with Manufacturing, Warehouse and Quality Systems teams to ensure accurate documentation, maintain GMP compliance and support timely batch disposition.
You will provide shop-floor quality oversight, investigate documentation discrepancies and ensure manufacturing records meet applicable quality standards. This is a floor-based, onsite position requiring a proactive and detail-oriented QA professional with hands-on experience in pharmaceutical or biotechnology manufacturing environments.
What you do
- Focus on 50–60% GMP label issuance, reconciliation and label control
- Focus on 30–40% operational and APS batch record review
- Focus on 10–20% shop-floor QA support, investigations and continuous improvement
- Work closely with Manufacturing, Warehouse and Quality Systems teams
- Provide shop-floor quality oversight
- Investigate documentation discrepancies
- Ensure manufacturing records meet applicable quality standards
- Support timely batch disposition
What they ask
- Experience in Quality Assurance within a GMP-regulated pharmaceutical or biotechnology manufacturing environment
- Knowledge of GMP documentation, label control and manufacturing quality processes
- Experience managing GMP label issuance, reconciliation, control and accountability
- Experience reviewing batch records, logbooks and other controlled manufacturing documentation
- Understanding of deviation reporting, discrepancy investigations and escalation processes
- Ability to verify label requests against approved documentation and production schedules
- Strong understanding of GMP compliance and manufacturing documentation requirements
- Strong attention to detail and ability to identify documentation errors, discrepancies and compliance risks
- Ability to review and approve manufacturing documentation to ensure accuracy, completeness and GMP compliance
- Ability to collaborate effectively with Manufacturing, Warehouse and Quality Systems teams
- Proactive, hands-on approach to shop-floor quality support
- Ability to support timely batch disposition through accurate and efficient QA documentation reviews
Preferences.
- Experience with aseptic processing and Aseptic Processing Simulation (APS) documentation
- Experience conducting operational and APS batch record reviews
- Previous experience providing shop-floor quality oversight and routine GMP monitoring
- Experience supporting inspections, audits and regulatory commitments relating to documentation and label control
- Experience identifying and escalating GMP concerns and documentation-related deviations
- Exposure to continuous improvement initiatives within manufacturing quality processes
Practicalities.
- Key Stakeholders: Manufacturing, Warehouse and Quality Systems teams
How to apply
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