Quality Control Microbiologist
Carries out basic and advanced microbiological techniques in the quality control laboratory including method verification, microbial limits testing, and environmental monitoring.
- Performs, analyzes, and interprets QC and microbial limits testing according to USP and regulatory requirements for raw materials, finished products, and stability samples.
- Perform environmental monitoring which includes water sampling and testing.
- Act as a backup to Microbiology Team Leader as needed.
- Train analysts on microbiology methods and sampling techniques.
- Performs investigations and completes CAPA in response to laboratory investigations.
- Manages change controls effectively.
- Manages/ supports microbiology projects from production or formulations development dept.
- Actively participates in customer and regulatory audits.
- Develops and executes validation protocols for test methods and equipment qualification.
- Author and review SOPs and test methods related to microbiology.
- Ensure the microbiological integrity of environment, equipment and facilities.
- Manages product testing based upon internal and customer specifications.
- Managing 3rd party laboratory testing and reporting of data and EM when necessary.
- Report on testing results, including CoA’s.
- Maintain equipment, media, and sample logs as needed.
- Ensure the micro lab is adequately supplied and maintained.
- Perform other responsibilities to support the business as requested.
- Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear.
- Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible.
- Stop work where deemed necessary to maintain safety.
Minimum Education Level Required:
Preferred Field of Study:
Minimum Years Required Experience:
Preferred Field of Experience: