Analyst, Quality Control - Clinical Release & Stability (1 of 3) - 2306121568W
Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control - Clinical Release & Stability (CRS)! This position will be located in Malvern, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group, LLC, is part of the Janssen Pharmaceutical Companies.
Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!
The QC CRS Analyst is responsible for conducting biochemical and testing of raw material, in-process, final product release and characterization samples, including CAR-T. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 – 10 other Analysts within a functional Clinical Release and Stability (CRS) Laboratory and report to the Senior QC Supervisor.
Conduct analytical biological testing of clinical and commercial drug product/drug substance samples
Perform peer reviews and approvals of laboratory data
Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing including application of statistical concepts to laboratory data
Support of New Product Initiatives (NPI) including owning a project and perform project management functions with limited to no coaching from supervision/management
Perform Instrument Calibration and/or Preventative Maintenance
Update CRS-owned documents using the Document Management System (DMS)
Order/receive supplies and manage inventory
Support analytical method qualification, validation, and transfer into and out of the QC lab, owning change control actions, completing testing activities with mentorship from Sr. Analysts on transfer activities
Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight
Act as a peer subject matter expert in assessing talent by participating in panel interviews for job
Complete invalid assay and general laboratory investigation records
Complete corrective and preventative actions (CAPA) as assigned
Assist in the execution of internal audits
- Minimum of a Bachelor’s or equivalent University degree is required with a focused degree in Biology, Biochemistry, Microbiology, Chemistry or related field preferred.
Experience and Skills:
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 laboratoryor equivalent environment and solid understanding of cGMP and current Good Laboratory Practices (GLPs)
Experience with one or more of the analytical technologies used in the Cell and Gene Therapy Laboratories such as qPCR, cell culture, Flow Cytometry, and/or ELISA
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)
CAR-T, Cell and Gene Therapy, or Biochemistry laboratory experience
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 lab (BSL 2, BSL2 ) or aseptic facility
Experience, training, or certification in Lean, Six Sigma, or Process Excellence tools & methodologies
Knowledge of EU/FDA guidance
Requires ability and flexibility to accommodate unplanned overtime (including nights and weekends) on little to no prior notice outside of Monday-Friday 8:00AM to 4:30PM.
Requires the physical ability to lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting, and ability to perform visual inspections of materials (color, appearance, particles, etc.) and to document observations during laboratory testing
Requires up to 5% of domestic travel
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Primary Location NA-US-Pennsylvania-Malvern
Organization JANSSEN SUPPLY GROUP, LLC (6046)
Travel Yes, 10 % of the Time
Job Function Quality Control
Req ID: 2306121568W