QA Investigations Specialist III- (Two openings)
About The Position
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 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.
Requirements
- Bachelor’s Degree in Life Science or related field or equivalent is 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.
Responsibilities
- 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
