QC Clinical Release & Stability; CRS) Analyst

Quality

Quality Control

Professional

Malvern, Pennsylvania, United States of America

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The QC Clinical Release & Stability (CRS) Analyst is responsible for performing analytical testing of cell and gene therapy products, critical reagents, and characterization samples in support of clinical and commercial manufacturing. This role executes testing activities in compliance with current Good Manufacturing Practices (cGMP), laboratory procedures, and regulatory requirements while ensuring the timely release of high-quality data.

The CRS Analyst works collaboratively with Quality Assurance, Manufacturing, Analytical Development, and other cross-functional partners to support product release, method transfers, investigations, and continuous improvement initiatives. This position requires strong technical expertise, attention to detail, critical thinking, and a commitment to quality and patient safety.

• Perform analytical testing of drug substances, drug product, characterization, stability, and critical reagent samples.
• Execute assays including, but not limited to:
  Flow Cytometry qPCR/ddPCR ELISA Cell-Based Assays Endotoxin Testing Other biochemical and microbiological methods as applicable
• Ensure accurate and timely completion of testing activities according to approved procedures and specifications.
• Document testing activities in accordance with ALCOA+ and GMP requirements.

• Review laboratory data for accuracy, completeness, and compliance.
• Complete testing records, notebooks, electronic records, and reports in approved systems such as eLIMS, MES, Empower, and EDMS.
• Support laboratory investigations, deviations, CAPAs, and invalid assay assessments.
• Maintain training records and remain qualified on assigned analytical methods.

• Support new product introductions (NPI), method qualification, validation, and technology transfer activities.
• Participate in implementation of new methodologies, instrumentation, and laboratory technologies.
• Contribute to process optimization, digital transformation initiatives, and business excellence projects.
• Identify opportunities to improve efficiency, compliance, and data integrity.

• Maintain laboratory equipment through routine calibration, maintenance, and troubleshooting activities.
• Manage laboratory inventory, reagents, and consumable supplies.
• Ensure laboratory areas remain inspection-ready and compliant with safety standards.
• Participate in internal audits, regulatory inspections, and compliance initiatives.

• Partner with Quality Assurance, Manufacturing, Analytical Development, and Operations teams to ensure successful execution of testing activities.
• Assist with training and mentoring new analysts.
• Actively participate in team meetings and departmental initiatives.
• Promote a culture of quality, safety, accountability, and continuous improvement.

• Bachelor's degree in Biology, Biochemistry, Microbiology, Chemistry, Biotechnology, or related scientific discipline required.

• 3 years of laboratory experience in a pharmaceutical, biotechnology, medical device, or related industry.
• Familiarity with GMP and laboratory documentation practices.
• Experience with biological or analytical testing methods.
• Ability to interpret SOPs, test methods, protocols, and technical documents.
• Strong organizational, communication, and problem-solving skills.
• Proficiency with Microsoft Office applications and electronic laboratory systems.

• Cell and Gene Therapy, CAR-T, biologics, or advanced therapies experience.
• Experience with Flow Cytometry, PCR technologies, ELISA, Cell Culture, or Endotoxin testing.
• Knowledge of laboratory investigations, CAPAs, and change control processes.
• Experience in a GMP-regulated QC laboratory environment.
• Basic knowledge of Compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC
• Experience developing and…