- Responsible for all matters involving Microbiology including but not limited to testing of raw materials, finished product and testing required for various process validations.
- Operation of incubators, autoclaves and associated equipment in a microbiological laboratory.
- Responsible for operation of the Microbiology Lab in a Regulated site manufacturing OTC drugs, medical devices, and cosmetics.
- Perform all administrative duties pertaining to this position.
- Maintain, review (for accuracy) and file laboratory notebooks for Micro lab observing Good Documentation Practices. As the Senior Microbiologist, routinely issue approval for Microbiology Test results.
- Per Good Manufacturing Practices (GMP) responsible for regular review and updating of written procedures and protocols pertaining.
- Responsible for timely alert (to QC Supervisor or QA Manager) of potential quality issues with raw materials or finished product.
- Must possess knowledge of all day to day techniques in a Microbiology Lab (culture preparation and growing, seeding, streaking, reading plates, etc.).
- Capable of advising QA Manager on Microbiological issues.
- Serve as spokesperson for the company when dealing with customer complaints that may touch upon Microbiology.
- Self-starter, hands-on professional committed to improving lab operations in support of production, processes, and quality. Ability to work in a high-volume laboratory in a manufacturing plant and supervise one technician.
Experience & Skills Required
- 5-7 years of relevant test experience in a Microbiology Lab within a regulated industry (Pharmaceutical, Medical Device, Food etc.).
- Ability to take initiative to solve problems involving Microbiological testing.
- Must be experienced in Microbiological assays of antibiotics and bio-burden testing.
- Knowledgeable of USP Test Methods particularly USP <61>, <62> (TAPC, Y/M and Specific Organism tests).