Manager Quality - Microbiology

Consumer Product Partners Llc - Smyrna, TN

Full-time - Manager

Smyrna, TN

About the position

The Manager Quality - Microbiology is responsible for overseeing the microbiology department within a consumer product manufacturing facility. This role involves managing staff, ensuring compliance with regulatory requirements, and maintaining quality standards for microbiological testing. The manager will mentor and train associates, develop policies and procedures, and ensure the reliability and accuracy of laboratory results while fostering a positive quality culture.

Responsibilities

• Manage all aspects of the Analytical Quality Control Function.
• Ensure compliance with all applicable regulatory requirements including FDA, EPA, DNR, BATF, and OSHA.
• Advise, instruct, develop, and implement policies and procedures to improve operations and maintain compliance.
• Mentor and train associates on policies and procedures.
• Oversee and supervise staff and related activities in the microbiology department.
• Develop, implement, and maintain quality specifications and standards for all raw materials, bulk, and finished goods.
• Perform testing on all samples submitted for analysis, including stability and method development.
• Plan and forecast departmental staffing needs and interview job applicants.
• Assign work tasks to lab members to ensure an efficient QC function.
• Provide ongoing supervision and career development for QC personnel.
• Review customer complaints and work with other departments to address concerns.
• Develop and validate new methods and procedures, ensuring adequate training is conducted.
• Coordinate and approve all OOS & incident investigations, deviations, and NCRs.
• Monitor change controls for effects on micro-sensitive products or processes.

Requirements

• Bachelor's degree in Microbiology or related field.
• Minimum of 12 years in a leadership role in an OTC drug or medical device manufacturing facility, with a majority in a Microbiology Lab environment.
• Extensive experience in representing FDA regulated drug manufacturing sites during audits.
• Comprehensive knowledge of the FD&C Act and 21 CFR Parts 210/211 & 11.
• Minimum of 5 years QC/QA experience in a regulated industry, preferably food, drug, or cosmetic.
• Minimum of 3 years leadership experience.
• Demonstrated proficiency in a laboratory environment, time management, project development, and prioritization.
• Experience in wet chemistry operations and operation of laboratory instrumentation.

Nice-to-haves

• Experience with FDA audits and customer audits including contract customers and 3rd party auditors.
• Knowledge of current Good Manufacturing Practices (cGMP).
• Excellent organizational skills and ability to analyze data.

Benefits

• Health insurance
• 401k retirement plan
• Paid holidays
• Professional development opportunities
• Flexible scheduling