QA Investigations Specialist III- (Two openings)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently seeking a QA Investigations Specialist III to join our QA team located in Raritan, NJ!

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Johnson & Johnson Innovative Medicine, 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 releases of materials related to the production of CAR-T and 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:

Qualifications

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

• Provide quality/compliance guidance to resolve quality related issues and/or documentation discrepancies to site personnel.

• Represent the department in interdepartmental meetings in support of process improvement initiatives.

• Escalates issues to management in timely manner and works with management to address and remediate issues.

• Respond swiftly to departmental and interdepartmental needs and requests.

• Support site inspections, inspection readiness activities, data integrity efforts and additional continuous improvement activities.

• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.

• Other duties will be assigned, as needed.

Education:

• Minimum of four (4) years of experience in Quality Assurance, Quality Systems or Compliance 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.

• Demonstrat