J&J Family of Companies Senior Analyst, Quality Control - Clinical Release & Stability (CRS) in Malvern, Pennsylvania
Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Analyst, Quality Control - Clinical Release & Stability (CRS)!
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 Senior 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
Lead analytical method qualification, validation, and transfer into and out of the QC lab, owning change control actions, leading and coordinating testing activities, and mentoring newer 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 Degree in Biology, Biochemistry, Microbiology, Chemistry, or related field
Experience and Skills:
Minimum four (4) 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)
Detailed knowledge and proficiency of 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
Detailed knowledge of Compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC
Technical writing experience (e.g., author investigations, test method revisions, protocols, assay/equipment logbook creation, SOPs, and/or Work Instructions) and the ability to read/interpret technical documents
Proficient with Microsoft Office applications (Outlook, One Note, Teams, Excel, Word, and PowerPoint)
CAR-T, Cell and Gene Therapy, or Biochemistry laboratory experience
Ability to complete equipment and software qualification protocols
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
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
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 .
United States-Pennsylvania-Malvern-200 Great Valley Parkway
JANSSEN SUPPLY GROUP, LLC (6046)
J&J Family of Companies
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