New

Quality Control Analyst

Digital Prospectors
United States, Massachusetts, Woburn
Jun 11, 2025
Position:Quality Control Analyst, Gene Therapy Location:Woburn, MA (Onsite) Length:7+ months Job Description: Our client is seeking a Quality Control (QC) Analyst to join its Quality Control Bioassay team. This role supports the development, validation, and routine testing of analytical methods for gene therapy products, specifically those utilizing AAV (Adeno-Associated Virus) vectors. The QC Analyst will be responsible for executing cell-based assays, immunoassays (e.g., ELISAs), and other biological methods in a regulated GMP environment. This is an excellent opportunity for an individual with a background in molecular or cell biology to contribute to the quality and development of life-changing therapies in a collaborative and fast-paced setting. Essential Duties and Responsibilities (but not limited to): Execute immunoassays and cell-based assays to support GMP testing for product release and stability. Author and review technical documentation, including Standard Operating Procedures (SOPs), protocols, and reports. Assist in the development, transfer, and validation of late-stage bioassays related to gene therapy programs. Review, analyze, and trend QC data independently to ensure compliance with regulatory standards. Participate in deviation investigations, root cause analyses, and performance trending of analytical methods. Maintain and support operations in the QC Bioassay lab, including instrument maintenance, cell passage, and reagent qualification. Collaborate with cross-functional teams and external testing laboratories to ensure project success. Qualifications: Bachelor's degree in Cell Biology, Molecular Biology, Biochemistry, or a related scientific discipline. Minimum of 2 years of industry experience in a QC or analytical laboratory setting. Hands-on experience with mammalian cell culture techniques is strongly preferred. Proficiency in performing immunoassays such as ELISAs is required; experience with cell-based potency assays is a plus. Familiarity with statistical analysis and data interpretation is beneficial. Strong attention to detail and the ability to work independently in a dynamic, fast-paced environment. Excellent communication, collaboration, and organizational skills. POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment. Come see why DPC has achieved: 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 'Employee's Choice - Best Places to Work' by Glassdoor. Voted 'Best Staffing Firm to Temp/Contract For' seven times by Staffing Industry Analysts as well as a 'Best Company to Work For' by Forbes, Fortune and Inc. magazine. As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today! www.LoveYourJob.com