Quality Control Associate II

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 LIMS
• Maintain compliance with GMP regulations and internal SOPs and methods
• Initiate, lead and participate in deviations, Change Controls and CAPAs
• Perform preventative maintenance of QC equipment

Requirements

• 3-5 years of experience in a GMP-regulated pharmaceutical or biotech industry
• Experience with cell and flow cytometry-based assays
• Working knowledge of LIMS systems
• Ability to work a fixed Wednesday through Saturday shift (10 hours/day)
• Strong organizational and GDP skills
• Ability to stand for extended periods and work in a laboratory environment wearing PPE

Preferred Qualifications

• Prior experience in cell therapy environments
• Experience with MasterControl
• Experience with BMRAM
• Familiarity with FCS Express software
• Bachelor’s or Master’s degree in biology, Immunology, Cell Biology, or related field

Benefits

• Subsidized medical, dental, and vision plans
• 401(k) Plan with Company match
• ESPP and Equity Incentive Plan
• 18 days vacation, 9 days sick leave, and 8 observed holidays
• Summer and winter office shutdowns