Quality Control Analyst, Biologics

Kelly® Science & Clinical is seeking Quality Control Analysts for contract-to-hire opportunities with one of our clients, a global biopharmaceutical company focused on oncology 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: Quality Control Analyst, Biologics

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 studies—demonstrating precision, accuracy, and unwavering adherence to cGMP standards. You’ll 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 <788>), 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 years’ laboratory experience in a regulated cGMP environment is highly desirable.

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.