
Description
QC Chemistry Analyst Location: Princeton, NJ
Department: Quality Control Reports To: QC Manager Key Responsibilities:
- Perform QC analytical testing for drug substances (DS), drug products (DP), and stability samples to support product release and manufacturing timelines.
- Conduct routine lab operations including instrument calibration, qualification, maintenance, and reagent/supply inventory management.
- Generate and revise SOPs, testing specifications in compliance with cGMP guidelines. Execute and support laboratory investigations such as OOS, OOT, deviations, and invalid assay results.
- Implement and monitor CAPAs following root cause analysis.
- Participate in method transfer and validation activities, including protocol development, execution, and reporting.
- Bachelor's degree or higher in Chemistry, Biochemistry, Biotechnology, or a related scientific field.
- Minimum of 2 years of QC experience in a GMP-regulated pharmaceutical or biotechnology setting.
- 5+ years of relevant experience preferred if no formal degree.
- Proficient in analytical methods for biologics, including but not limited to:
- HPLC/UPLC, Gas Chromatography (GC), Total Organic Carbon (TOC)
- UV-Vis Spectrophotometry, Sub-visible Particulate Testing
- Container Closure Integrity Testing (CCIT), N-glycan profiling
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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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.
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