Quality Control Associate II

Key Responsibilities

• Perform cell-based release and stability assays for cell count, viability and cytotoxicity.
• Execute release lentiviral vector assay to determine titer and potency.
• Perform flow cytometry in-process, release and stability testing.
• Support and execute method transfer, qualification and validation.
• Participate in authoring test methods and developing and validating blueprints for testing in LIMSM.
• Maintain compliance with GMP regulations and internal SOPs and methods during all QC operations.
• Initiate, lead and participate in deviations, Change Controls and CAPAs.
• Perform preventative maintenance of QC equipment, and ensure clean and organized laboratories.

Requirements

• 3-5 years of experience in a GMP-regulated pharmaceutical, biotech, or related industry.
• Prior experience in cell therapy environments is a plus.
• Working knowledge of LIMS systems is strongly preferred.
• Detail-oriented with strong organizational and GDP skills.
• Able to work independently on a fixed schedule (Weds-Sat, 10 hours/day).
• Ability to stand for extended periods and work in a laboratory environment wearing personal protective equipment.
• Ability to lift up to 25 lbs occasionally.

Qualifications

• Bachelor’s or Master’s degree in biology, Immunology, Cell Biology, or related field.
• 3–5+ years of experience working in a GMP-regulated laboratory environment.
• Experience with cell and flow cytometry-based assays is required.
• Familiarity with software tools for flow cytometry data analysis (e.g. FCS Express).
• Strong attention to detail, organizational skills, and ability to work independently on a fixed schedule (Weds-Sat).