Category: Scientific & Clinical
Title: QC Microbiology Supervisor
Location: South Brunswick, NJ
Type: Direct Hire
Start date: ASAP
Growing Biotech company looking to hire immediately! Looking for Environmental Monitoring leader.
- Coordinate with contract lab for sample shipments and data for outsourced sterility, endotoxin, growth promotion and ID tests.
- Knowledgeable for environmental monitoring during cleaning validation and EMPQ activities.
- Support QC by executing analytical test, raw material release and QC dossier review.
- Supervise daily operations of Microbiology Lab including direct reports.
- Subject Matter Expert for EM nonconformance investigations and risk analysis.
- Train Microbiology and Manufacturing staff in EM procedures including Operation of Counters, Gown Qualification and EM Sampling.
- Author or revise EM Standard Operating Procedures.
- Execute trend analysis of EM data and support quarterly EM report submission.
- Minimum of a BS degree, preferably in Microbiology
- 5+ years’ experience of Environmental Monitoring, Sterility, Endotoxin testing in compliance with cGMP guidelines
- Experience doing risk assessments
- Experience with cleaning validation
- Experience with Trend data, writing reports and SOPs, deviations and nonconformance investigations
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.