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Johnson & Johnson · 8 hours ago

Quality Control- Clinical Release & Stability (CRS) Analyst

Malvern, Pennsylvania, United States of America

Full-time

Onsite

Entry, Mid Level

2+ years exp

Johnson & Johnson is a leader in healthcare innovation, focusing on developing treatments and cures for complex diseases. The Quality Control- Clinical Release & Stability (CRS) Analyst will conduct biochemical testing and ensure compliance with applicable procedures and GMP regulations in the testing of drug substances and products.

Hospital & Health Care

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Conduct analytical biological testing (ELISAs, qPCR, Flow Cytometry, Cell-based assays, etc.) of clinical drug substance, drug product, characterization, and/or critical reagent samples

Perform peer reviews and approvals of laboratory data

Use electronic systems (eLIMS, MES, Empower, etc.) for execution and documentation of laboratory data

Support of New Product Introductions (NPI) in groups of 3-6 analysts

Support analytical method qualification, validation, and transfer into the CRS lab, owning change control actions, generation of new documentation, and completing testing activities with mentorship from Sr. Analysts on transfer activities

Perform Instrument Calibration and/or Preventative Maintenance, as needed

Order/receive supplies and manage inventory

Update CRS-owned documents using the Electronic Document Management System (EDMS)

Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight

Complete invalid assay and support laboratory investigation records

Complete corrective and preventative actions (ACTs), as assigned

Assist in the execution of internal audits or inspections

Qualification

QPCRCGMP complianceAnalytical testingBiochemistryFlow CytometryELISALean Six SigmaMicrosoft OfficeCell cultureTechnical document interpretation

Required

Minimum of a Bachelor's or equivalent degree in Biology, Biochemistry, Microbiology, Chemistry or related field is required

Minimum two (2) years of relevant work experience

Experience in Medical Device, Biopharmaceutical, or Pharmaceutical industry

Working experience in a current Good Manufacturing Practices (cGMP) compliant QC laboratory or equivalent environment and solid understanding of cGMP and current Good Laboratory Practices (GLPs)

Experience with the analytical technology of qPCR

Ability to read/interpret technical documents such as SOPs, work instructions, test methods and protocols

Proficient with Microsoft Office applications (Outlook, One Note, Teams, Excel, Word, and PowerPoint)

Preferred

CAR-T, Cell and Gene Therapy, or Biochemistry laboratory experience

Experience with analytical technologies used in the CRS Laboratory such as qPCR, cell culture, Flow cytometry, and/or ELISA

Basic knowledge of Compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC

Ability to complete equipment and software qualification protocols

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

Company

Johnson & Johnson

Glassdoor4.2

At Johnson & Johnson, we believe health is everything.

Founded in 1886

New Brunswick, NJ, US

10001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (48)

2024 (56)

2023 (58)

2022 (59)

2021 (44)

2020 (27)