QC Microbiologist- Princeton, New Jersey- Full Benefits, 401K and PTO
Essential Functions of the Job:
Perform utilities sampling for Water for Injection (WFI), Purified Water (PW), Clean Steam, and Process gases.
Conduct environmental monitoring of cleanroom suites and laboratory areas as required.
Perform QC Microbiology laboratory testing, including bioburden, endotoxin, sterility, and microbial identification testing, to ensure timely generation and reporting of test results for in-process, drug substance, drug product, and stability samples in support of manufacturing operations.
Support routine QC operations, including instrument qualification and maintenance, SOP generation and revision, specification updates, record-keeping, and archival.
Conduct laboratory investigations, including Out of Specification (OOS), Out of Trend (OOT), deviations, and invalid assays.
Implement Corrective Actions and Preventive Actions (CAPAs).
Participate in facility qualification activities for microbiological testing and environmental monitoring.
Required to gown into cleanrooms with different classifications and stand/move around for extended periods.
Participate in method transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.
Core Competencies, Knowledge, and Skill Requirements:
Bachelor’s Degree or higher in Microbiology, Biology, Biotechnology, or a related scientific discipline. Minimum of 2 years of experience in an FDA-regulated biotechnology or pharmaceutical company.
5+ years of experience preferred for candidates without higher education.
Strong working knowledge and hands-on experience with microbiological testing methods such as endotoxin testing, bioburden, sterility testing, microbial identification, PCR, biological indicators, and environmental monitoring.
Familiarity with USP/EP and cGMP/EU GMP regulations.
Experience with instrument and equipment validation.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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