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.
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
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
