Microbiology Supervisor

QC Microbiology Supervisor

The QC Microbiology Supervisor is responsible for the day-to-day management and operation of the microbiology laboratory, ensuring compliance with cGMP, regulatory requirements, and company quality standards. The position reports to the site Quality Control Manager.

Functions of The Job:

1. Behavior: Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts, all day, every day.
2. Attendance: Present for work when scheduled is a mandatory function.
3. Safety: Compliance with all company safety rules, procedures, and guidelines is essential.
4. Develops, implements, and maintains quality specifications and standards for all raw materials, bulk, and finished goods.
5. Reviews and approves microbiological test results and recommends disposition decisions for raw materials, in-process materials, stability samples, and finished products in accordance with approved specifications and procedures.
6. Oversee the environmental monitoring program, including sampling plans, trend analysis, investigations of action-level excursions, identification of microorganisms, and periodic program review.
7. Oversee microbiological monitoring and trending of purified water systems.
8. Performs microbiological risk assessments related to raw materials, manufacturing processes, environmental monitoring excursions, product contamination events, and change controls.
9. Leads and approves microbiological investigations including OOS, OOT, deviations, contamination events, adverse trends, laboratory incidents, and customer complaints. Identifies root causes, implements corrective and preventive actions (CAPAs), and verifies effectiveness.
10. Perform trend analysis on all microbiological data.
11. Trains and mentors Microbiology laboratory personnel.Assign work tasks to lab members to ensure efficiency.
12. Provides on-going supervision and career development path to Micro personnel. Conducts performance evaluations, assists employees in resolution of work-related problems.
13. Provides technical assistance and interface with other departments to improve efficiency, workflow, and cost savings.
14. Develops and validates new methods and procedures. Communicates new procedures to others and ensures adequate training is conducted.
15. Advocates GMP & GLP regulations and ensures that all laboratory activities and documentation meet compliance standards (FDA, EPA, ATF, OSHA etc.).
16. Reviews and revises all laboratory policies, procedures, test methods, and job descriptions as needed.
17. Actively participates in cross functional teams to ensure quality standards are maintained at the site.
18. Ensures all instruments and laboratory equipment are performing within calibration and adequately maintained to meet GMP & GLP regulations.
19. Maintains lab supplies.