This position is responsible for microbiological cGMP testing of sterile products developed and manufactured onsite. This includes routine microbiological testing of products for release and stability (i.e. microbial enumeration, endotoxin, sterility, antimicrobial effectiveness, and microbial identification), development and validation of microbiological methods, monitoring and maintaining the laboratory in good quality, assisting in the validation and periodic certification of the manufacturing facility, developing and executing equipment protocols, and performing work in a safe, accurate and professional manner.
The Microbiologist performs the release and stability testing of manufactured products and works closely with manufacturing to support operations and manufacturing processes.
- Use microbiological equipment and techniques for testing such as sterility, endotoxin, microbial identification, antimicrobial effectiveness testing, and microbial enumeration while under minimal supervision.
- Perform routine and qualification testing of raw materials and product for release and stability; Author qualification reports and technical methods summarizing test results. Testing and associated documentation is performed and reviewed in a timely manner with high accuracy and reliability.
- Ensure laboratory operations in support of microbiological testing is maintained such as making media, performing growth promotion, preparing working organism cultures, sterilizing materials, maintaining supplies.
- The employee should successfully meet schedules in a high quality and professional manner and ensure work areas conform to cGMP regulations, Standard Operating Procedures and Corporate Policies.
- Peer review of laboratory notebooks for accuracy and compliance to microbiological methods.
- Revise standard operating procedures (SOPs) for the microbiology laboratory; revisions may be related to procedural improvements, customer requests and/or audit observations.
- Perform investigations; write problem reports prior to QA review; write and complete deviations and Corrective and Preventative Actions (CAPAs); interact with customers as needed.
- Maintain accurate inventory and tracking records of supplies and equipment; Revise, review, and execute IQ/OQ/PQ protocols on laboratory equipment; Troubleshoot and make minor repairs to laboratory equipment; Ensure good housekeeping and maintain benches, laboratory, and supply rooms are in a clean and orderly manner in accordance with cGMP’s, USP and FDA requirements.
- Interact with other departments, including quality assurance and production, to ensure a smooth overall workflow.
- Set annual goals with supervisor to improve job and individual skills and abilities; Maintain a high level of quality of product and improved established efficiency and yield standards.
- All other duties as assigned by management.
Minimum Education and Experience:
- Bachelor’s degree and 1 – 3 years related experience in quality control/cGLP/cGMP laboratory Or equivalent combination of relevant education, experience and training