Sr QA Specialist IMSC NC CAPA

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Cork, Cork, Ireland

Job Description:

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...