QC Clinical Release & Stability (CRS) Analyst
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About this opportunity
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com .
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.
Job Function:
Quality
Job Sub Function:
Quality Control
Job Category:
Professional
All Job Posting Locations:
Malvern, Pennsylvania, United States of America
Job Description:
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re 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 https://www.jnj.com/medtech
We 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
Bachelor’s 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 https://www.jnj.com/contact-us/careers. 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 parent’s consent for the background check.
#LI-Onsite
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 1523 comparable Quality roles across 149 biopharma companies.
Salary context
248 of 1523 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1523 comparable roles
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Seniority mix
690 of 1523 peers have a known seniority level
Therapeutic area mix
1 of 1523 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
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How we calculate "similar"
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.