Laboratory Quality Assurance Specialist
1 week ago
Job Summary
Joulé is seeking a highly skilled Microbiologist III to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality and safety of our products.
Key Responsibilities
- Coordinate microbiological testing, release of product, and testing for validation protocols.
- Perform organism identification and technical review of batch filling records to ensure quality of aseptic processes.
- Read and interpret microbiological cultures and other related tests, including environmental monitoring, sterility tests, growth promotion, and microbial limits tests.
- May perform validation, technology transfer, and troubleshooting, and write policy procedures for quality initiatives.
- Review and approve environmental monitoring data and laboratory equipment and records.
- Prepare process and status reports, assign and monitor document numbers, and review documents for accuracy and completeness.
- Perform other functions as required or assigned.
Requirements
- Bachelor's degree in a relevant field.
- 3 years of relevant experience in microbiology or a related field.
- Experience with environmental monitoring (EM), aseptic techniques, bioburden and endotoxin testing, and water for injection sampling (WFI sampling).
- Experience with Veeva Vault and autoclave operation is a plus.
- Ability to travel between company sites as required.
Benefits
Joulé offers eligible employees a comprehensive benefits package, including health and welfare benefits, 401(k) plan, and other perks.
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