Quality Control Analyst, Biologics

Kellyu00ae Science & Clinical is seeking Quality Control Analysts for contract-to-hire opportunities with one of our clients, a biopharmaceutical company focused on metabolic diseases in Vacaville, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries. Workplace: Vacaville, CA. Position Title: Analytical Development Scientist Position Type: 6-month Contract Pay rate: $40-60 per hour Client Overview Join a dynamic, globally engaged biotechnology company at the forefront of developing and manufacturing cutting-edge protein therapeutics. Our state-of-the-art cGMP facility in Vacaville, CA supports clinical programs spanning North America, Europe, and Asia-Pacific, delivering investigational biologic treatments for a range of oncology and rare disease indications. As we expand our team, we seek passionate professionals dedicated to upholding the highest standards of quality and innovation in the production of vital therapies for patients and partners worldwide. Role Summary As a Quality Control Analyst (Analytical), you play an essential role in ensuring the consistent quality and compliance of biological drug products. You will independently conduct a wide range of biochemical, physical, and chemical analyses across process development, lot release, and stability studiesu2014demonstrating precision, accuracy, and unwavering adherence to cGMP standards. Youu2019ll be empowered to grow your skill set with training in advanced analytical technologies, helping bring transformative therapies to patients in critical need. Key Responsibilities + Conduct biochemical, physical, and chemical testing of raw materials, in-process, and final product samples under cGMP, meeting project timelines and quality expectations. + Provide technical support and actively troubleshoot analytical test methods to ensure robust and reliable laboratory outcomes. + Initiate and participate in OOS/OOE/OOT investigations; draft deviation reports and lead laboratory investigations as required. + Maintain laboratory operations in an audit-ready state and support continuous process improvement. + Author and revise SOPs, test methods, protocols, and Change Control documents, ensuring full compliance and traceability. + Mentor and train analysts on analytical procedures and instrument operation. + Manage inventory and coordinate calibration and maintenance of laboratory equipment and reagents for assigned areas. + Collaborate cross-functionally with Manufacturing, Quality Assurance, and process teams to meet program milestones and regulatory requirements. + Adhere rigorously to cGMP, 21CFR, USP, EP, ICH, and other applicable quality regulations. Expertise and Skills + Thorough knowledge of cGMP and regulatory standards (21CFR 210/211, USP, EP, ICH). + Proficient in routine operation and troubleshooting of modern analytical instrumentation; strong documentation and record-keeping abilities. + Strong written, verbal, and interpersonal communication skills; able to work independently as well as collaboratively. + Computer proficiency, including Windows and Microsoft Office (Excel/Word). + Ability to train and mentor junior staff on laboratory procedures and best practices. Preferred Technical Experience + Hands-on experience with HPLC/UPLC, SDS-PAGE, protein analytics, subvisible particle testing (USP ), CCIT, and Chromatography Data Systems (OpenLab or similar). + Capable of supporting complex investigations involving instrument performance or reagent standardization. Qualifications + B.S./B.A. degree in Biology, Biochemistry, Chemistry, or a related scientific discipline. + A minimum of 5 yearsu2019 laboratory experience in a regulated cGMP environment is highly desirable. + Ability to occasionally lift to 25 lbs; must possess close vision, depth perception, and the ability to adjust focus as required for laboratory tasks. Accelerate your biotech career in a collaborative, mission-driven environment where quality fuels therapeutic innovation. Apply now to make a difference, helping deliver the next generation of biologic therapies to patients worldwide. #P1 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 u00ae 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 worldu2019s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsu2014itu2019s 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, weu2019re obsessed with where it can take you. To us, itu2019s about more than simply accepting your next job opportunity. Itu2019s the fuel that powers every next step of your life. Itu2019s 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 lifeu2014just 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 Californiau2019s 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.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 Kellyu2019s Human Resource Knowledge Center. Kelly complies with the requirements of Californiau2019s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Created: 2026-04-13