Senior Specialist, CAPA Management
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Job Description
Senior Specialist CAPA Management at Johnson & Johnson ensuring compliance in CAPA processes. Collaborating with stakeholders to monitor investigations and manage quality approvals.
Responsibilities:
- CAPA reviewer/approver for CAPA Management Process: Facilitate the initiation of investigations and CAPAs, and monitor progress and approvals.
- Collaborate with key stakeholders to support the end-to-end NC/CAPA process.
- Ensure that CAPA procedures and requirements are followed and met.
- Escalate complex issues to CIM management for resolution.
- Work with stakeholders, senior management, and governance bodies for awareness and resolution, as needed, including any issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records.
- Review evidence and approve closure of CAPA plans.
- Monitor effectiveness of CAPAs to ensure the Root Cause is eliminated or reduced to acceptable level.
- Drive key deliverables and ensure timely completion of activities.
- Support/Provide regular updates for CAPA status, metric reports, and trending, as needed.
- Participate in and/or support internal audits and regulatory inspections, as needed.
- Attend, participate and/or facilitate CAPA review meetings, as needed.
- Perform other duties as necessary.
Requirements:
- Bachelor’s Degree in Life Science or related discipline or equivalent is required.
- Knowledge and experience with regulations and regulatory compliance issues.
- At least 8+ years of experience in an applicable compliance field and or equivalent experience/training in a related R&D area.
- Experience with Non-Conformance/CAPA.
- Analytical and data skills.
- Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence.
- Must be a problem solver, strategic thinker, 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.
- Ability to build and maintain cross-functional interactions and coordination.
- Ability to build consensus, influence, and negotiate.
- Knowledge in R&D related activities which may include safety-related areas, safety reporting for both investigational and marketed products, clinical study coordination, etc.
- Knowledge of Quality Management, Project Management and/or Process Excellence concepts and practices.
Benefits:
- None specified
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