QC Microbiology Associate
3 weeks ago
Business Title: QC Microbiology Associate
Location: Cambridge, MA
Job Type: 12+ Months contract
PARKING IS ROUGHLY $420/mo
Job 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
- Assist in the generation, review and approval of protocols, reports, and CofA
- Perform environmental monitoring and utility samples of the facility
Skills & Experience Required
- Bachelor's degree in relevant field
- 3+ years of experience
- Knowledge of GMP, microbiology, aseptic technique, and general laboratory instrumentation
- Experience performing lab investigation, deviation writing, participate in change controls, and CAPAs investigations
- Bioburden and endotoxin testing experience
- A background authoring and revising standard operating procedures
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