Summary

Carries out basic and advanced microbiological techniques in the quality control laboratory including method verification, microbial limits testing, and environmental monitoring.

Key Accountabilities

• 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:

Bachelor’s Degree

Preferred Field of Study:

Microbiology/Science Discipline

Minimum Years Required Experience:

5

Preferred Field of Experience:

Pharma cGMP