AP QA Specialist (Aseptic Processing) - FDA Readiness brContract: 2 months, 40 hours/week brStart: Immediate (FDA readiness deadline: June) brLevel: Mid-Senior Specialist brAbout the Role brA 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. brKey Responsibilities brAseptic Process Compliance Review brConduct a retrospective review of media fills on BS3 and IWK3, mapping operators to interventions and confirming compliance. brReview all authorized aseptic interventions and verify appropriateness of related mitigation measures. brPerform a complete Aseptic Process Simulation (APS) rational review. Risk Assessment QA Oversight brUpdate risk assessments for direct and indirect product-contact surfaces in aseptic processes. brConduct an impact assessment supporting the justification of current Preventive Maintenance (PM) acceptance criteria. brPerform a risk‐based evaluation of validated interventions, defining worst‐case scenarios. brReview and classify maintenance activities to establish appropriate QA oversight requirements. Set‐Up, Personnel Monitoring Readiness brReview IWK3 and BS3 set‐up processes, defining the validated sequence and the point at which equipment achieves Grade A readiness for EM sampling. brUpdate assessment of personnel monitoring limits across aseptic operations. brEvaluate glove‐sampling practices, including the assessment of using one plate per glove. Quality Alarm Management brReview management of quality alarms in SCADA, ensuring proper acknowledgement, justification, root cause analysis, and QA oversight. Requirements br5+ years in aseptic processing, sterile manufacturing, or pharmaceutical QA. brIn‐depth understanding of EU Annex 1 and FDA aseptic guidance. brProven experience with media fills, interventions, equipment readiness, and risk‐based decision making. brAbility to join mid‐stream and deliver results quickly. brStrong communication, analytical, and documentation skills.