Job Description
Job Responsibilities:
- 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.
- Performs 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 as area SME.
- 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
Skills:
- Investigations and completes CAPA.
- Environmental monitoring which includes water sampling and testing
Education/Experience:
- Education: Associate's degree or higher
- 3+ years' experience
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