QA Investigations Specialist III- (Two openings)
$94,000–$151,800 year
On-siteRaritan, New Jersey, United States
Raritan, New Jersey, United StatesOn-siteFull Time$94,000–$151,800 yearEnterprise
Full TimeEnterprise
Job Summary
Review NC and CAPA records for documentation completeness, root-cause analysis quality, and regulatory compliance. Provide coaching on CAPA methodologies, monitor progress, and confirm root causes are eliminated. Collaborate with issue owners, site owners, and governance bodies to resolve conflicts and escalate risks. Compile metric reports, trending analyses, and status updates to inform continuous improvement. Support internal audits, regulatory inspections, and SC NC CAPA review meetings. Partner with business process owners to sustain processes and enhance the J&J Quality Systems Platform.
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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