Quality Assurance Specialist II

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Janssen Pharmaceutical a member of Johnson & Johnsons Family of Companies is recruiting for a QA Specialist II! This position will be 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 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.

In this role you will be providing quality oversight for daily activities related to the production of viral vectors in a controlled cGMP environment. You will act as a liaison with other internal quality organizations to standardize policies practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.

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!

Main Responsibilities will include but are not limited to:

• Partner with Operations teams to support production activities in a cGMP manufacturing facility.

• Perform review and approval of completed batch records and production documentation in support of batch release activities including preparation of product release documentation.

• Provide quality oversight for incoming shipments of raw materials working cell banks and consumables and outgoing shipments of viral vector drug substance.

• Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.

• Author and revise Quality departmental documents.

• Review and approve controlled documents including standard operating procedures master batch records work instructions protocols and reports and technical studies.

• Participate in continuous improvement activities.

• Supports site inspections and inspection readiness activities. Ensure the site is audit ready. Support data integrity efforts.

• Other duties may be assigned as necessary.

Qualifications

Education:

• A minimum of a Bachelors Degree is required with a focused degree in Engineering Science or equivalent technical field preferred.

Skills & Experience:

Required:

• Minimum 2 years of industry experience in a regulated manufacturing environment preferably in biotechnology or pharmaceutical industry.

• Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) regulations and FDA/EU guidance

• Ability to be organized and capable of working in a team environment with a positive demeanor.

• A high degree of accuracy and attention to detail and excellent interpersonal oral and written communication skills.

• Ability to work independently on routine tasks.

• Ability to maintain written records of work performed in paper-based and computerized quality systems.

Preferred:

• Experience with quality support in clinical or GMP manufacturing or support of QC laboratories is preferred.

• Experience with the manufacture of cell and gene therapy products as well as knowledge of Good Tissue Practices is preferred.

Other:

• Requires ability and flexibility to work 8-hour shifts 1st shift Monday - Friday and provide occasional off shift or weekend support as needed.

• This position is located primarily in Raritan NJ and may require up to 5% local travel.

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.

#CAR-T

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