QA Investigations Specialist III- (Two openings)

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. Qualifications 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. 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. Salary & Benefits Position is located primarily in Raritan, NJ and may require up to 5% local travel. Anticipated base pay range: $94,000.00 – $170,000.00 USD per year. 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)). Time‑off benefits include: Vacation – 120 hours per calendar year; Sick time – 40 hours per calendar year (48 hours for Colorado, 56 hours for Washington); 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 period; Volunteer Leave – 32 hours per calendar year; Military Spouse Time‑Off – 80 hours per calendar year. Additional general information on Company benefits: https://www.careers.jnj.com/employee-benefits Employment Equity 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. #J-18808-Ljbffr