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Johnson & Johnson Innovative Medicine · 3 days ago

Quality Control- Clinical Release & Stability (CRS) Analyst

Malvern, PA

Full-time

Onsite

Entry, Mid Level

2+ years exp

Johnson & Johnson is a leader in healthcare innovation, dedicated to developing treatments and pioneering solutions for complex diseases. The Quality Control- Clinical Release & Stability (CRS) Analyst will conduct biochemical testing and ensure compliance with GMP regulations while supporting the development of cell and gene therapy products.

Pharmaceuticals

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 CytometryELISAMicrosoft OfficeLean Six SigmaCellGene TherapyBiosafety Level Lab

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)