QA Investigations Specialist III- (Two openings)

Johnson & Johnson Innovative Medicine•Raritan, NJ

2d•Onsite

About The Position

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!

Requirements

Minimum of four (4) years of experience in Quality Assurance, Quality Systems or Compliance preferred.
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.
Demonstrated experience supporting manufacturing investigations
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.

Nice To Haves

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.

Responsibilities

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.

Benefits

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.
Bonuses are awarded at the Company’s discretion on an individual basis.