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Cellares

Posted 12 months ago

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Quality Control Analyst

Bridgewater, NJOn-siteFull-time

AI Summary

Quality Control Analyst responsible for routine and non-routine analytical testing in a cGMP biotech setting, including in-process, raw material, and stability testing, with oversight of data integrity and regulatory compliance.

About this role

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

    • Skills

    Calibration/maintenanceCAPACell-based Potency AssaysCOA/COT PreparationDeviation InvestigationDPCRELISAFlow CytometryIn-process TestingMethod DevelopmentMethod ValidationOOS/OOT InvestigationsQPCRRaw Material TestingRegulatory SubmissionsSOP DevelopmentStability TestingTech TransferTraining RecordsValidation Protocols

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