Sterility Assurance Senior Consultant
ProPharma Group
ProPharma Group seeks a senior consultant with sterility assurance expertise to conduct detailed manufacturing and quality data reviews for a 2-3 month engagement in Kansas City. The role supports product impact assessments and retrospective lot evaluations across environmental monitoring, aseptic processing, and related quality functions.
Responsibilities
- Execute lot-review activities following approved protocols and procedures
- Analyze manufacturing, environmental, aseptic, and visual inspection data
- Conduct product impact assessments and document technical conclusions
- Identify recurring quality trends and sterility assurance concerns
- Support development of technical justifications and final reports
Requirements
- 7+ years of experience in sterility assurance
- Expertise in environmental monitoring and aseptic processing
- Experience with investigations and batch disposition assessments
- Proficiency reviewing manufacturing deviation and complaint data
- Ability to identify quality trends and escalate findings appropriately
Vacancy posted 4 days ago
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