Microbiology Supervisor

POSITION TITLE: QC Microbiology Supervisor

Department: Quality

Reports To: Micro Manager

FLSA Status: Exempt (Salary)

Prepared By: Department Manager

QC Microbiology Supervisor

The Micro Supervisor’s main roles would be the day-to-day operation of the microbial lab and release of products. Communicates day-to-day laboratory activities with the Micro Manager.

Coordinates and approves all OOS & incident investigations, deviations, and NCRs. Ability to complete Phase I and II of OOS investigations.

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. Oversees testing on all samples submitted for analysis, including stability, method development, and R&D support.
6. Trains and mentors Micro personnel on policies and procedures. Assign work tasks to lab members to ensure an efficient QC function.
7. Provides on-going supervision and career development path to Micro personnel. Conducts performance evaluations, assists employees in resolution of work-related problems. Provides coaching and leadership to all personnel.
8. Provides technical assistance and interface with other departments to improve efficiencies, work flow, and cut costs. Communicates effectively throughout the organization to ensure quality issues are addressed.
9. Develops and validates new methods and procedures. Communicates new procedures to others and ensures adequate training is conducted.
10. Advocates GMP & GLP regulations and ensures that all laboratory activities and documentation meet compliance standards.
11. Ensure compliance with all applicable regulatory requirements including FDA, EPA, DNR, BATF, and OSHA.
12. Actively participates in all safety programs.
13. Coordinate and approve all OOS & incident investigations, deviations, and NCRs. Ability to complete Phase I and II of OOS investigations.
14. Reviews and revises all laboratory policies, procedures, test methods, and job descriptions
15. Actively participates in cross functional teams to ensure quality standards are met.
16. Coordinates with QC staff to provide support to ensure raw materials, bulk and finished product meet OTC release timing.
17. Ensures all instruments and laboratory equipment are performing within calibration and adequately maintained to meet GMP & GLP regulations.
18. Maintains lab supplies.

ducation Requirements:

Bachelor’s degree in Microbiology or related field and 6 years microbiology laboratory experience.

Experience Requirements:

A minimum of 8 years in a leadership role in an OTC (over-the-counter) drug or medical device manufacturing facility, with a majority of that experience in a Microbiology Lab environment. Experience in representing an OTC company during customer audits including contract customers and 3rd party auditors. A comprehensive knowledge of the FD&C Act and 21 CFR Parts 210/211 & 11 along with industry required standards for pharmaceutical and OTC drugs. Superior communication and leadership skills required.

Competencies:

Project management, technical writing, data analysis, knowledge of Microbiology laboratory testing and practices, and knowledge of current Good Manufacturing Practices are mandatory.

Certificates, Licenses, Registrations: N/A

Travel: Very Minimal

Work Environment:

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

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 accommodations 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 frequently is 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 l