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QA Specialist, Lentivirus

Company: Johnson & Johnson
Location: Raritan
Posted on: February 24, 2021

Job Description:

Job DescriptionJanssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Specialist, Lentivirus.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 Biotech, Inc. is part of the Janssen Pharmaceutical Companies.Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.The QA Specialist, Lentivirus Will* Support the establishment of QA activities for Lenti Viral Vector (LVV) production in Raritan, NJ* Identify deviations and support in finding resolutions to maintain the Lenti Viral Vector production in compliance.* Oversee the execution of unit operations according to standard operating procedures and batch records.* Review recorded production data and information and ensure the data is clear, concise, and formatted according to Good Documentation Practices (GDP)* Perform tasks on time in a manner consistent with the safety policies, quality systems and cGMP requirements.* Work in a team based, cross-functional environment to complete production tasks required by schedule.* Drive continuous improvement of LVV production leveraging own observations, as well as input of team members.* Conducts QA review of batch records and release of LVV material.* Ensures completeness and accuracy of all files received into Quality Assurance, according to SOP and to meet state and federal regulatory requirements.* Ensures readiness of records for regulatory inspection.* Revises existing standard operating procedures as needed.* Develop Standard Operating Procedures for quality activities within LVV production.* Performs other QA duties as assigned.* Detailed knowledge of Johnson & Johnson Quality and Compliance standards.EducationQualifications* A minimum of a bachelor's degree is required, preferably in Biology, Engineering, Science, or equivalent technical discipline.Experience* A minimum of four (4) years of experience in Quality Assurance related to manufacturing is required.* Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development is preferred.* A minimum of two (2) years of experience with quality support in clinical manufacture or NPI is preferred.Skills/Abilities* Knowledge of cGMP regulations required.* International manufacturing regulatory knowledge is preferred.* Strong interpersonal and written/oral communication skills are required* Ability to quickly process complex information and often make critical decisions with limited information is required* Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities is required* Proficient in applying process excellence tools and methodologies is preferred* Ability to independently be responsible for a portfolio of ongoing projects is preferred* Ability to pay attention to details and follow the procedures is required* The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.* Experience with team-based collaborations is required* Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) required, and current Good Tissue Practices (cGTP) related to CAR-T manufacturing is required* Ability to identify/remediate gaps in processes or systems is preferred.* Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required* Experience with CFR parts 600, 601, and 610 is preferred.* Experience reviewing/auditing documentation including but not limited to: Batch Records, SOPs, Work Instructions is required* Able to use Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) is required* Flexible to work in weekends, and after hours, as needed is requiredJohnson & 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.

Keywords: Johnson & Johnson, Trenton , QA Specialist, Lentivirus, Other , Raritan, New Jersey

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