Sr QA Specialist IMSC NC CAPA

Duties & Responsibilities:

NC CAPA Quality System Investigation Process: Supply Chain Implementation

• Support efficient and effective investigation training/certification. Support NC/CAPA system and process user training

• 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.

• Support NC/CAPA system and process user training, including investigation certification.

• Facilitate initiation of investigations and CAPAs and monitor progress to ensure timely completion.

• Execute 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.

• 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 stakeholders, site owners, governance bodies, and senior management to resolve issues and align on corrective actions; escalate risks or compliance issues to the Senior Manager, Quality Systems CAPA as needed.

• Coordinate with IMSC sites and responsible functions to drive completion of assigned actions.

• Partner with site NC/CAPA business process owners and J&J Quality Systems Platform Governance to sustain processes and support platform enhancement requests.

• Ensure the IMSC NC/CAPA process remains inspection-ready and support audits/inspections.

• Provide coaching and actionable feedback to issue owners on CAPA best practices, system usage, and investigation execution.

•  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

Education & Experiences:

• Bachelor’s Degree in Life Science or related discipline or equivalent is required.

• Knowledge and experience with regulations and regulatory compliance issues.

• Minimum of 6 years’ experience in a regulated MedTech or Pharmaceutical Quality Systems Compliance field and/or equivalent experience/training in a related NC CAPA Investigation Quality System area.

• Demonstrated experience as an investigator of Non-Conformance/CAPA process.

• Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence.

• Requires critical analytical and problem-solving skills, 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 of Quality Management, Project Management and/or Process Excellence concepts and practices.

• Other core skills: strong attention to detail, excellent time management, relationship-building, and experience with CAPA systems, investigative techniques, and data-driven quality improvement.

Decision-making & Problem-solving:

• Ability to work independently and coordinate across Supply Chain driving compliance to the NC CAPA Global Process.

• Requires basic management skills for cross-functional interactions and coordination.Facilitates resolution of issues and able to collaborate with stakeholders at varying levels of management across multiple organizations.

• A fundamental understanding of the risk management process to engage key stakeholders and mentor colleagues to capture insights and make risk-based decisions.

• Excellent communication and writing skills demonstrated by the ability to write executive summaries and ad hoc reports promptly and clearly as well as compile and present data to other professionals.

• Requires data analytical skills to examine data and perform analysis.

• Requires decision-making skills to approve the appropriateness, effectiveness, quality and compliance of documented robust investigations, root cause analysis and corrective/preventative action plans.

Working relationships/interfaces:

• Must be able to effectively operate in a matrixed environment and interact with cross functional leaders on a regular basis.

• Senior Manager/Director, NC CAPA – interfaces and informs as needed to discuss issues.

• CAPA and Issue Management team members – interfaces daily as needed to manage workload, interfaces weekly in team meetings.

• Supply Chain, Global Quality Systems, R&D Senior Management, R&D Quality, Regulatory Affairs, Medical Affairs, and other business functions involved in owning investigations and delivering CAPA commitments - interfaces as needed to address identified issues and provide guidance on established processes.

• J&J partners – must be able to effectively interact with third-party organizations, and marketing partners as needed to address cross-company and cross-departmental issues.