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Sterility Assurance Assessment Lead
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Full-time
- Lexington, MA (Hybrid) - onsite 3 days a week / 2 days from home
- Delivery of Current State Contamination Control Findings Report Execution of microbial and/or cross contamination LOPA, HACCP &/or FMEA in identifying and assigning risk (RPN) of identified GAPs to define prioritization in overall CAPA Plan. Delivery of Corrective and Preventive Action Plan based upon risk to remediate GAPs identified in Assessment.
- Management and oversight of defined CAPA Plan with assigned Stakeholders at site; to drive delivery and promptly elevate concerns and/or roadblocks.
- Signification experience (7+ years) supporting site compliance to the global microbial/viral control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, cleanroom management, microbiological methods and validations including RMM, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments.
- Signification demonstrated experience in development and delivery of risk based CAPA plans.
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