QA Specialist II - Johnson and Johnson
Raritan, NJ 08869
About the Job
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.
In this role, you will be providing quality oversight for daily activities related to the production of cryopreservation of human apheresis and testing 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 related Advanced Therapy products in a cGMP manufacturing facility.
- Perform review of production documentation and provide guidance to resolve quality related manufacturing issues and/or documentation discrepancies.
- Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
- Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans.
- 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.
- Perform regularly scheduled oversight of manufacturing activities in a controlled clean room environment.
- Supports site inspections and inspection readiness activities. Ensure the site is audit ready. Support data integrity efforts.
- Other duties may be assigned as necessary.
- A minimum of a Bachelor's Degree is required, with a focused degree in Engineering, Science or equivalent technical field preferred.
Required:
- Minimum 2 years of industry experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry, is required.
- 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.
- 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.
- Requires ability and flexibility to work 10-hour shifts 2nd shift. Work Tues-Fri 2nd shift (10 hours) one week, Work Wed-Sat 2nd shift (10 hours) other week, and repeat and provide occasional off shift support, as needed.
- This position is located primarily in Raritan, NJ, and may require up to 5% local travel.
- The anticipated base pay range for this position is $60,000 to $96,600
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 .