Quality Assurance Specialist ||

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 One Quality Assurance Specialist II to join our QA team located in Raritan, NJ! This position will have the following shift Wednesday- Saturday or Sunday- Wednesday 7:30-6pm with a preference for the Wednesday- Saturday shift flexibility.

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 II, is an exempt level position with responsibilities for providing quality attributes over a wide range of activities and projects in the CAR-T facility to support clinical and commercial efforts to release material for human use.

Key Responsibilities:

• Review released documentation for all manufacturing activities executed in accordance with Good Documentation Practices (GDP).
• Work in a team based, cross-functional environment to complete tasks required to meet business objectives.
• Support Investigations team by providing quality and compliance input for continuous improvement and remediations.
• Review, revise, or draft Standard Operating Procedures (SOPs) in relation to the quality process.
• Contribute to process improvement of batch release and turnaround times to ensure turnaround times and QA batch release deadlines.
• Perform duties/tasks under minimal direction/supervision according to standard operating and manufacturing procedures and demonstrate ability to attain resources and information from established internal contacts.
• Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements.
• Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
• Ensure readiness of records for regulatory inspections and internal audits.

Qualifications:

Education:

Minimum of a Bachelor’s degree in Science, Information Science or equivalent technical discipline is required  

Experience:

Minimum of 2 years of experience in Quality Assurance/Quality Systems/Compliance

Skills/Abilities:

• Knowledge of cGMP/GTP regulations and FDA
• Good written and verbal communications skills
• Experience working with in large molecules, or CAR-T production. Knowledge of International regulatory guidelines. e.g. EU Guidance

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 https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
#CAR-T

Required Skills:

 

 

Preferred Skills:

 

 

The anticipated base pay range for this position is :

$65,000.00 - $104,650.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits