Description
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.
- 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.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Apply on company website