Quality Control Analyst

Responsibilities

• Conduct routine and non-routine analytical, biochemical, and/or biological analysis such as, in-process materials, raw materials, finished goods, or stability samples
• Work with cell therapy products and associated assays (dPCR, qPCR, cell-based potency assays, proliferation assays, ELISA, flow cytometry assays, etc.)
• Perform timely and accurate peer review of analytical test results/reports
• Prepare COA/COT for testing performed
• Identify discrepancies, initiate and investigate OOS/OOT results for phase 1 and phase 2
• Initiate and investigate deviations related to quality control
• Compile and review data to ensure accuracy and regulatory compliance
• Support development for specifications and justification of specifications
• Participate in validation and technical transfer of analytical methods commensurate with experience
• Write and revise test methods
• Maintain required training and training records and provide training to qualify other associates
• Participate in internal assessments and audits as required
• Support equipment validation, calibration, maintenance, and troubleshooting
• Write method validation protocol/reports and other documentation such as test reports
• Write stability protocol and stability reports
• Write and revise Quality Control Standard Operating Procedures
• Supply Quality Control data necessary for regulatory submissions
• Support Quality Systems such as; change control, deviation, CAPA, audits, quality metrics, etc.
• Assist in general upkeep of the laboratory and maintain a clean work environment
• Perform other duties as assigned

Requirements

• Bachelor's degree in a science discipline required, or comparable experience
• 2+ years of experience in cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment, is preferred
• Prior experience related to method development/validation
• Prior experience with immune cell phenotyping by multicolor flow cytometry, dPCR, qPCR, cell-based potency and other cell therapy related assays is preferred
• Knowledge of pharmaceutical cGMP (US and EU) is preferred
• Must have excellent verbal, written, interpersonal, and organizational and communication skills
• Must be able to commute to Bridgewater, New Jersey
• Excellent verbal, written, organizational, presentation and interpersonal skills
• Self-awareness, integrity, authenticity, and a growth mindset