Quality Control Microbiology Supervisor
Scope of Function:
Responsible for supervision of the Microbiology Laboratory. Create, review and revise SOPs related to testing and sampling. Organize and schedule Microbiology activities. Represent QC Microbiology in production meetings and other meetings as required. Participate in audits, if necessary.
Quality Control Manager or higher.
1. Ensure competent performance of microbiology personnel.
2. Create or revise departmental SOPs.
3. Maintain the quarterly report for the Microbiology lab tracking all Alerts, Actions, or OOS.
4. Perform all relevant microbiology tests and reports.
5. Review and approve all micro test results.
6. Maintain, review and approve all equipment log books associated with the Microbiology Lab.
7. Coordinate in-house and outside testing.
8. Keep Microbiology area in a tidy, organized and in a sanitary condition at all times.
9. Create, execute and compile qualification/validation protocols and reports related to Microbiology.
10. Write deviations, investigations, OOS and change control reports
11. Conduct training for new recruits and company wide on topics pertaining microbiology and aseptic technique.
12. Excellent verbal and written communication skills.
13. Assist in ordering/inventory of lab supplies.
Education and Skills Required:
Education: Four-year college degree in Microbiology or related science is required.
Experience: Must have at least five years work experience in GLP/GMP FDA regulated environment
Skills: Environmental Monitoring of the clean rooms
USP sterility and Bioburden
USP Water Testing
Total Organic Carbon
Please send your cover letter and attached resume to: click here
Goodwin Biotech - 23 months ago