We are seeking an innovative, creative, and detail-oriented Quality Control Analyst to join our team in Bridgewater, New Jersey. This position will be responsible for routine and non-routine QC testing according to Standard Operating Procedures (SOPs).  This role supports the day-to-day operations within the Quality Control group via execution of analytical testing. This includes but is not limited to in-process testing, lot release testing, stability testing, and raw material testing. All activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.

This role will be a hands-on resource reporting to the Senior Director, Quality Control Bioanalytics.  

Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.




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