QA Lab Oversight Specialist III

Janssen Pharmaceuticals is recruiting for a QA Lab Oversight Specialist, located in Raritan, NJ!

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 Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.

The QA Lab Oversight role is an exempt level position with responsibilities for providing quality oversight for Raritan site Quality Control laboratories. The responsibility includes reviewing and approving, of standard operating procedures (SOPs)/ Forms, validation/ qualification/ method transfer protocols/ reports, completed assay data for testing of pre-clinical, clinical, and commercial stage CAR-T cellular therapy products tested in QC labs which includes In Process, Release, Critical Reagents and Microbiology labs, Monthly Lab audits, initial approval for retest for SST/AAC/ SAC failures. Closure of QIs related to SST/AAC/ SAC.

Key Responsibilities:

• Provides quality oversight for site Quality Control laboratories responsible for testing clinical and commercial stage CAR-T cellular therapy products in accordance with J&J policies, standards, procedures, and Global cGMP.
• Work with QC organization to support the successful transfer of QC Lab functions to the Raritan cGMP facility to test products.
• Review and approve Technical Documents, Investigational Reports, Completed Daily Assay Data, Personnel Gowning and Pipette Qualifications, Data Generated Reports and CoA's as applicable.
• Support the release of patient sample materials.
• Provide Quality feedback to QC Management by performing spot-checks in the QC Laboratories to ensure compliance.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Strengthen QC Culture and recognize patterns/trends in Shop floor behaviour, reported data and communicate to management trending issues for improvement opportunities.
• Provide mentorship to other employees in the interpretation of quality issues and participates in the development of technical or scientific initiatives and activities.
• Routinely recognize and resolve quality issues. Seeks management perspective on quality issues.
• Act as liaison for the quality team to guide and improve site improvement projects and strategies.
• Learn and develop within the business as a Subject Matter Expert on quality assurance topics.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Qualifications

Education:

• Minimum of a Bachelor's Degree required; focused degree in Science or Engineering Technologies preferred

Experience and Skills:

Required:

• A minimum of 4 years relevant work experience is required.
• Knowledge of GxP regulations and FDA/EU guidance related to manufacturing of biopharmaceuticals.
• Ability to quickly process information and make critical decisions with minimal oversight.
• Ability to independently be responsible for a portfolio of ongoing projects.
• Ability to pay attention to details and follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive approach under some supervision.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Ability to identify/remediate gaps in processes or systems.
• Experience with cell and/or gene therapy analytical technique (e.g. flow cytometry, qPCR)
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
• Ability to work with others in a team environment and strong interpersonal and written/oral communication skills.

Preferred:

• Experienced in cGMP aseptic manufacturing environments, preferably in quality control, quality assurance, manufacturing, compliance, clinical quality, or cell and gene therapy
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP). Knowledge of current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing
• Detailed knowledge of CAR-T QC test methods and related equipment is helpful.
• Proficient in applying process excellence tools and methodologies (Six Sigma), such as MES, SAP, PAS-X or similar.

Other:

• Requires ability and flexibility to work 8-hour shifts between the operational hours of 8:00 AM – 5:00 PM Monday - Friday, and provide occasional support including nights, weekends, or other shifts with little or no prior notice
• This position is anticipated to have up to 10% travel
• The salary for this position is anticipated to be between $75,000 - $110,000.

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 .

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