QA Specialist - Environmental Monitoring
AP QA Specialist (Aseptic Processing) - FDA Readiness
Contract: 2 months, 40 hours/week
Start: Immediate (FDA readiness deadline: June)
Level: Mid-Senior Specialist
About the Role
A leading pharmaceutical manufacturer is seeking an experienced AP QA Specialist to support critical aseptic processing readiness activities ahead of an upcoming FDA milestone. This role requires a hands‑on specialist capable of delivering rapid, compliant results within a fast‑paced remediation environment.
Key Responsibilities
Aseptic Process Compliance & Review
- Conduct a retrospective review of 2024-2025 media fills on BS3 and IWK3, mapping operators to interventions and confirming compliance.
- Review all authorized aseptic interventions and verify appropriateness of related mitigation measures.
- Perform a complete Aseptic Process Simulation (APS) rational review.
Risk Assessment & QA Oversight
- Update risk assessments for direct and indirect product-contact surfaces in aseptic processes.
- Conduct an impact assessment supporting the justification of current Preventive Maintenance (PM) acceptance criteria.
- Perform a risk‑based evaluation of validated interventions, defining worst‑case scenarios.
- Review and classify maintenance activities to establish appropriate QA oversight requirements.
Set‑Up, Personnel Monitoring & Readiness
- Review IWK3 and BS3 set‑up processes, defining the validated sequence and the point at which equipment achieves Grade A readiness for EM sampling.
- Update assessment of personnel monitoring limits across aseptic operations.
- Evaluate glove‑sampling practices, including the assessment of using one plate per glove.
Quality Alarm Management
- Review management of quality alarms in SCADA, ensuring proper acknowledgement, justification, root cause analysis, and QA oversight.
Requirements
- 5+ years in aseptic processing, sterile manufacturing, or pharmaceutical QA.
- In‑depth understanding of EU Annex 1 and FDA aseptic guidance.
- Proven experience with media fills, interventions, equipment readiness, and risk‑based decision making.
- Ability to join mid‑stream and deliver results quickly.
- Strong communication, analytical, and documentation skills.
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