QC Microbiology associate in Cambridge, MA

POSITION TITLE: QC Microbiology Associate

DURATION: 1 Year (Potential for extension)

100% ON SITE

• The QC Microbiology associate is responsible for the performance of the cGMP routine/non-routine QC sampling and testing within the function of the QC Microbiology Laboratory supporting our Vaccine manufacturing site.
• This is a first shift position.

Key Responsibilities:

• Perform routine environmental monitoring of the manufacturing facility.
• Perform routine sampling and testing of the utility systems.
• Perform Manufacturing Process Monitoring Perform QC sample receipt and aliquoting as necessary.
• Complete documentation in accordance with current Good Manufacturing Practices (cGMP) ensuring data integrity.
• Support Laboratory investigation, deviation management and CAPA.
• Maintain QC Micro related systems to ensure compliance with industry standards supporting internal/external audits.
• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies.

Required Qualifications

• BS in a relevant scientific discipline or 2-5 years Quality Control experience in a cGMP organization with a focus in Microbiology
• Knowledge of GMP, microbiology, aseptic technique, and general laboratory instrumentation (preferred)
• Experience performing lab investigation, deviation writing, participate in change controls, and CAPAs investigations.
• Assist in the generation, review and approval of protocols, reports, and CofA
• Ability to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment.

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