QA Investigations Specialist III- (Two openings)
$94,000–$151,800 year
On-siteRaritan, New Jersey, United States
Job Summary
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. Requires 6+ years in a regulated field, Bachelor's degree in Life Science, and ability to work 8-hour shifts Monday-Friday with occasional weekend support.
Required Qualifications
- Bachelor's Degree in Life Science or related field
- 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
- Ability and flexibility to work 8-hour shifts 1st shift Monday - Friday
- Ability to provide occasional off shift or weekend support
- Up to 5% local travel
Desired Qualifications
- Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence
- Critical analytical and problem-solving skills
- Strategic problem solver
- Collaborator
- Excellent organization, prioritization, and time management skills
- Adaptability
- Attention to detail
- Ability to build and maintain relationships and partnerships across the organization
- Strong attention to detail
- Excellent time management
- Relationship-building
- Experience with CAPA systems
- Investigative techniques
- Data-driven quality improvement
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