QA Investigations Specialist III- (Two openings)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 two Quality Assurance Investigation Specialist III to join our QA team located in Raritan NJ!

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 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 the Sr. Quality Specialist leads robustness of NC/CAPA investigations and approvals ensuring timely triage thorough root-cause analysis and effective corrective/preventive. This skilled and competent Quality Approver role will support monitoring progress provide feedback to investigation and CAPA owners resolve collaborator conflicts and escalate issues to senior management when required.

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!

• Complete quality reviewer/approver duties review evidence and approve closure of NC and CAPA records.
• Conduct investigation record quality reviews for documentation completeness robust root-cause analysis and compliance with procedures.
• Provide coaching and actionable feedback to issue owners on CAPA standard methodologies system usage and investigation execution.
• Collaborate with team members to support the end-to-end NC/CAPA process.
• Monitor CAPA effectiveness and confirm root cause is eliminated or reduced to an acceptable level.
• Use data analytics and trending to identify failure modes measure CAPA effectiveness and inform continuous improvement priorities.
• Compile and provide regular CAPA status updates metric reports and trending analyses.
• Collaborate with collaborators site owners governance bodies and senior management to resolve issues and align on corrective actions; escalate risks or compliance issues as needed.
• Partner with site NC/CAPA business process owners and J&J Quality Systems Platform Governance to sustain processes and support platform enhancement requests.
• Participate in and/or support internal audits and regulatory inspections as needed.
• Attend participate and/or facilitate SC NC CAPA review meetings as needed.
• Perform other duties as necessary.

Education:

• Bachelors Degree in Life Science or related field or equivalent is required.

Required:

• Knowledge and experience with regulations and regulatory compliance issues.
• Minimum of 6 years experience in a regulated field and/or equivalent experience/training in an investigations capacity.
• Demonstrated experience in an investigation related function.
• Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence.
• Requires critical analytical and problem-solving skills strategic problem solver and collaborator.
• Excellent organization prioritization and time management skills.
• Demonstrated competencies include adaptability attention to detail and ability to build and maintain relationships and partnerships across the organization.
• Other core skills: strong attention to detail excellent time management relationship-building and experience with CAPA systems investigative techniques and data-driven quality improvement.

• 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.
• The anticipated base pay range for this position is 94000.00 - 170000.00 USD annual

Johnson & Johnson is an Affirmative Action and 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 or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .

#CAR-T

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$94000.00 - $151800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys 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: - Experience:

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