Microbiology Supervisor (6269)

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.

Qualifications

Education Requirements:

Bachelor's degree in Microbiology, Biology, Biochemistry, or related scientific discipline and a minimum of 5 years of microbiology laboratory experience in a GMP-regulated industry. Post graduate coursework can be substituted for industry experience.

Experience Requirements:

1. Previous leadership experience in a GMP manufacturing facility, with most of that experience in a microbiology laboratory environment.

2. Experience as subject matter expert participating in customer, contract customers, and 3rd party regulatory audits.

3. A comprehensive knowledge of the FD&C Act and 21 CFR Parts 210/211 & 11 along with industry required standards for foods, pharmaceuticals, or cosmetics. For example: USP <60>, <61>, and <62>, microbial identification, and growth promotion.

4. Superior communication and leadership skills required.

Competencies:

Knowledge of Microbiology laboratory testing and practices, project management, technical writing, data analysis, and knowledge of current Good Manufacturing Practices are preferred competencies.

Certificates, Licenses, Registrations: N/A

Travel: Very Minimal

Work Environment:

This job is operated in a professional office environment and a microbiology laboratory. This role routinely involves standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines, and typical microbiology laboratory equipment.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

Physical Demands: Occasionally lift boxes of product 5-40 lb. Frequently lift samples 1-5 lb.