What are the responsibilities and job description for the Quality Control Microbiologist position at GroupA?
Job Type: Contract/40 hrs week
Location: Hopewell, NJ-Onsite
Duration: Until 09/07/2025, with opportunity to extend longer or convert to FTE based on performance/budget
Benefits: Medical, Dental, Vision, Supplemental Medical
Are you driven by the fascinating world of microbiology and biotechnology? Do you have a keen eye for detail and a passion for ensuring quality in every process? If so, we want you to be a part of our trailblazing team! We are seeking enthusiastic individuals with a background in Microbiology, Biology, or a related scientific discipline to support our cutting-edge projects and uphold excellence in our quality control laboratory.
- Utilities Sampling: Perform sampling of Water for Injection, Purified Water, Clean Steam, and Process gases.
- Environmental Monitoring: Conduct monitoring of cleanroom suites and laboratory areas to maintain optimal standards.
- QC Microbiology Testing: Execute laboratory testing, including bioburden, endotoxin, sterility, and microbial ID testing to ensure timely and accurate reporting of test results.
- Routine QC Operations: Support daily operations such as instrument qualification and maintenance, SOP generation and revision, specification updates, record keeping, and archival.
- Inventory Management: Oversee the inventory of reagents and supplies for the laboratory.
- Laboratory Investigations: Conduct investigations, including OOS, Out of Trend, deviations, and invalid assays, and implement corrective and preventive actions (CAPAs).
- Facility Qualification: Participate in qualification activities for microbiological testing and environmental monitoring.
- Method Validation: Engage in method transfer and validation activities, including protocol preparation, execution, and report writing.
- Additional Duties: Undertake any other tasks as required to support the team and achieve our goals.
What We're Looking For:
- Minimum of 2 years of experience in an FDA-regulated biotechnology or pharmaceutical company.
- Expertise in microbiological testing methods such as endotoxin, bioburden, sterility testing, microbial identification, PCR, biological indicators, environmental monitoring, etc.
- Familiarity with USP/EP and cGMP/EU GMP regulations.
- Proficiency in instrument and equipment validation.
- Analytical and Problem-Solving Abilities: Strong analytical skills and a hands-on approach with a 'can do' attitude.
Why Join Us?
- Innovative Environment: Be part of groundbreaking research and quality control in the biotechnology sector.
- Collaborative Team: Work with passionate professionals who share your dedication to excellence.
- Career Advancement: Opportunities for growth and professional development in a dynamic and rapidly evolving industry.
- Impactful Work: Contribute to projects that have a real-world impact on healthcare and environmental sustainability.
