Quality Control Specialist
About The Position
The Quality Control Specialist contributes to the cell therapy pipeline by qualifying analytical methods and performing testing that supports product lot release, in-process control, and stability monitoring. The role organizes, analyzes, and presents results, and helps ensure the QC Analytical laboratory operates reliably and compliantly. The specialist supports method development, qualification, and technical transfer from Analytical Development, and provides technical expertise in discussions, document reviews, and investigations. The role also authors or reviews analytical results, study summaries and reports, qualification protocols and reports, and standard operating procedures. It supports routine laboratory operations, including occasional off-hour or weekend technical support to meet release timelines; mentors and trains associate specialists; and identifies improvements to workflows, assay performance, and cycle time.
Requirements
- Associate’s degree in biological sciences or a related field and 4 or more years of experience; or bachelor’s degree in biological sciences or a related field and 2 or more years of experience; or MS in biological sciences or a related field and 0 or more years of experience.
- Flexibility to occasionally work weekends or holidays to support lot release testing.
- Demonstrated ownership, initiative, and self-accountability.
- Ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced, dynamic team setting.
- Attention to detail and ability to quickly learn and apply concepts and information.
- Knowledge of cell culture techniques.
- Proficiency in MS Word, Excel, PowerPoint, and other applications.
- Ability to communicate and work in a self-guided manner with scientific and technical personnel.
- Knowledge of analytical techniques such as flow cytometry, qPCR, dPCR, cell-based potency assays, and/or ELISA.
Nice To Haves
- Two or more years of relevant experience in the pharmaceutical or biotechnology industry.
- Experience in cell or gene therapy.
- Experience with analytical techniques such as flow cytometry, qPCR, dPCR, cell-based potency assays, and/or ELISA.
Responsibilities
- Perform flow cytometry, ELISA, cellular cytotoxicity, dPCR, and cell-based potency assays for release testing and stability monitoring of cell therapy products and in-process samples.
- Support analytical method development, qualification, and technical transfer from Analytical Development; design, execute, and document qualification activities.
- Serve as a subject matter expert in technical discussions, document reviews, and investigations, providing data-driven guidance to resolve issues and prevent recurrence.
- Author and/or review analytical test results, study data summaries and reports, method qualification protocols and reports, and standard operating procedures.
- Support daily QC analytical activities, monitor laboratory performance, and help ensure the laboratory operates as expected.
- Provide occasional off-hour or weekend technical support to meet lot release timelines.
- Mentor and train associate specialists and promote consistent analytical practice across the laboratory.
- Identify opportunities to streamline workflows, improve assay performance, and reduce cycle time.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health, dental, and vision coverage in accordance with applicable plan terms.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
