Upvote
Downvote
Sr. Manager, Microbiology And Sterility Assurance
Share Job
- Suggest Revision
- This position oversees the operations and management of the QC Microbiology laboratories performing environmental/critical utility monitoring, sterility testing and other client-specific microbiology testing in support of aseptic manufacturing operations.
- Oversight of laboratory compliance, operations and cross-functional interaction, oversight of laboratory validation activities as it relates to new equipment and methods, qualification and oversight of contract laboratories performing analysis on behalf of GRAM, resource planning as it relates to both personnel, facilities and equipment, strategic planning for future lab growth (technology, staffing, support systems, etc.)
- 10-12 years of prior experience in a regulated laboratory or pharmaceutical manufacturing environment at a minimum.
- A thorough understanding of cGMP, FDA guidelines and multinational regulatory/compendial standards is required; in-depth knowledge of other best practice resources such as PDA, ISPE, ICH, ISO, etc.
- Provide leadership to QC Microbiology Managers and senior personnel.
Active Job
Updated TodaySimilar Job
Relevance
Active