QC Analyst I – Bioassay

Job Description

Job Summary:

• The QC Analyst II role requires strong attention to detail, excellent organizational skills, computer proficiency, and a foundational understanding of laboratory instrumentation.
• The ideal candidate must also demonstrate effective communication skills and the ability to thrive in a fast-paced, highly technical laboratory environment.

Duties and Responsibilities:

• Perform cell-based immunological in vitro assays (e.g., MLR, cytotoxicity, HLA restriction, CTLp, cell proliferation, etc.) and operate related instrumentation.
• Apply knowledge of cGMP/GLP regulations and maintain accurate, compliant documentation to support Quality Control activities.
• Review QC test results for accuracy, precision, and compliance, ensuring timely completion of documentation aligned with product release timelines.
• Conduct data analysis, including study design, statistical evaluation, and preparation of written and oral reports/presentations.
• Record observations and results in trending databases for ongoing analysis and performance monitoring.
• Perform aseptic techniques and support mammalian cell culture activities, including maintenance and handling of cell lines.
• Support QC operations through inventory management, documentation control, log maintenance, and filing
  Participate in quality improvement initiatives and assist with laboratory investigations, including OOS, CAPA, and related quality events.
• Ensure adherence to Standard Operating Procedures (SOPs) and Good Documentation Practices (GDP) to maintain data integrity and traceability.
• Perform additional duties as assigned.

Qualifications:

• Bachelor’s degree in Biological Sciences or a related field preferred.
• 1–2 years of relevant experience in a laboratory, biotech, cell therapy, or related industry; or an equivalent combination of education and experience.
• Hands-on experience with aseptic technique and mammalian cell culture required.
• Familiarity with cGMP regulations as defined in 21 CFR 210 and 211.
• Experience with cell-based assays and molecular biology techniques preferred.
• Strong attention to detail with excellent written and verbal communication skills.
• Ability to work independently as well as collaboratively within a team environment.