Job Responsibilities - QC Microbiology Supervisor:
Supervision: Supervise the operations of the Quality Control Microbiology Department to ensure that finished products, raw materials, components, and processing facilities meet required specifications. Ensure that employees are properly trained and familiar with operational procedures. Conduct employee evaluations in a timely and accurate manner. Evaluate employee workload, ensuring a fair and equitable distribution within employee skills and experiences. Review time records and approve for payroll purposes. Conduct performance counseling as required. Train team members in microbiology procedures, providing ongoing guidance as required. Assist in training and providing guidance to co-workers outside laboratory in environmental monitoring and water sampling techniques.
Testing: Supervise all QC Microbiology Lab testing and activities including identify and isolate microorganisms, maintain and preserve cultures, environmental monitoring of aseptic process areas, growth promotion, microbial limit testing, media preparation, bioburden testing, method suitability, sterility testing of finished products, sterilization procedures including autoclave operation, equipment standardization and validation techniques. Assist in performance of testing as needed.
Documentation: Review data for accuracy to ensure specifications are met and evaluate for trending. Complete environmental releases. Conduct investigations and write summary reports as required. Evaluate data for adverse trends. Complete OOS, OOT, Deviation Reports, QC Alerts, and other documents as required. Read and evaluate current standards. Recommend new equipment and procedures. Develop laboratory methods and protocols. Evaluate, revise, and implement changes as necessary.
Meeting Participation: Attend various meetings to assist in environmental awareness, evaluation, and trouble-shooting. Conduct staff meetings. Participate in customer and FDA audits, as required. Develop and explain necessary data to audit team members. Provide tour of laboratory facilities as required. May be required to participate in external audits on occasion.
Administrative Tasks: Schedule necessary testing according to deadlines. Provide monthly environmental monitoring schedule. Schedule work assignments and duties and adjust as necessary according to priorities. Conduct review of laboratory notebooks and other required paperwork. Order and maintain inventory of environmental monitoring plates; supplies, and equipment. Schedule and send equipment for calibration repair. Meet with vendors to discuss current products, future products, problems, and projects. Schedule validations.
Training: Complete required qualification programs and other internal training. Attend seminars and study periodicals to maintain knowledge of contemporary techniques.
Education and Experience: Candidate should have a Bachelors Degree in Biology or Microbiology with 5 to 7 years experience in a lab setting, preferably a pharmaceutical microbiology lab. Candidates with extensive experience in lieu of a degree will be considered. Knowledge of FDA regulations, GMP, ISO, and USP is a requirement.
Job Responsibilities: QC Micro Analyst I and Environmental Monitoring Technician positions: may train for and participate in an array of pharmaceutical microbiology laboratory activities including environmental monitoring of aseptic process areas; bioburden testing, sterility testing, organism ID’s, LAL/Endotoxin testing, growth promotion, media preparation, maintaining laboratory notebooks and other required paperwork; maintaining supplies and equipment; sampling and testing of finished products, raw materials, and components according to established procedures. Knowledge of GMP and USP is a requirement. Able and willing to work in a fast-paced team environment. Able to work weekends and overtime as required.
Candidate should have an Associates Degree in Biology or Microbiology with 1 to 2 years’ experience in a lab setting, preferably microbiology lab. Candidates with relevant experience in lieu of a degree will be considered.