QC Clinical Release & Stability (CRS) Analyst

NCSL International

Northern (KY)

Hybrid

USD 70,000 - 100,000

Full time

42 hours ago

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Job summary

Johnson & Johnson is seeking a QC Clinical Release & Stability (CRS) Analyst in Malvern, PA to perform analytical testing of cell and gene therapy products and related materials. The role ensures data quality, compliance with cGMP, and timely product releases.

You will collaborate with QA, manufacturing, and analytical development, maintain documentation in eLIMS and Empower, and support method transfers, investigations, and continuous improvement efforts.

Qualifications

Bachelor's degree in Biology, Biochemistry, Microbiology, Chemistry, Biotechnology, or related field required.
3 years of laboratory experience in pharma/biotech or related industry.
Familiarity with GMP and laboratory documentation practices.
Experience with biological or analytical testing methods.

Responsibilities

Perform analytical testing of drug substances, drug product, characterization, stability, and critical reagents.
Execute assays such as Flow Cytometry, qPCR/ddPCR, ELISA, cell-based assays, endotoxin testing.
Document testing activities per ALCOA+ and GMP requirements.
Review data for accuracy and compliance; maintain records in approved systems.

Skills

GMP Knowledge

Lab Analysis

SOP Interpretation

Data Entry

Communication

MS Office

Education

Bachelor's degree in Life Sciences

Tools

eLIMS

MES

Empower

EDMS

Job description

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.

Required Skills:

Preferred Skills: