QC Clinical Release & Stability (CRS) Analyst

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for QC Clinical Release & Stability (CRS) Analyst located at Malvern PA.

Purpose:

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.

You will be responsible for:

Quality Control Testing

• 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.

Data Review and Documentation

• 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.

Method Transfer and Continuous Improvement

• 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.

Laboratory Operations

• 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.

Collaboration and Leadership

• 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.

Qualifications

Education

• Bachelors degree in Biology Biochemistry Microbiology Chemistry Biotechnology or related scientific discipline required.

Required Experience

• 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.

Preferred Experience

• 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 setting long-term objectives
• Experience working in Biosafety Level (BSL 2 BSL2) lab or aseptic facility
• Experience training or certification in Lean Six Sigma or Process Excellence tools & methodologies
• Knowledge of EU/FDA guidance
• Detailed knowledge and experience in applying statistical concepts to laboratory data.

Core Competencies

• Quality & Compliance Mindset
• Technical Scientific Expertise
• Data Integrity & Documentation Excellence
• Critical Thinking & Troubleshooting
• Collaboration & Teamwork
• Continuous Improvement
• Adaptability & Learning Agility
• Strong Attention to Detail.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via Internal employees contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment as well as get a parents consent for the background check.

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