Sr Analyst Quality Assurance

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Raritan, New Jersey, United States of America

Job Description:

POSITION SUMMARY:

The Sr.

Quality Specialist leads robustness of investigations and approvals, ensuring timely triage, thorough root-cause analysis, and effective corrective/preventive actions.

This skilled and competent Quality Approver role will support monitoring progress, provide feedback to investigation owners, resolve stakeholder conflicts, and escalate issues to senior management when required.

Investigation Quality System Investigation Process


* Execute quality reviewer/approver duties, review evidence, and approve closure of investigation 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 best practices, system usage, and investigation execution.


* Facilitate the progression of investigations and related actions and monitor progress and approvals.


* Collaborate with key stakeholders to support the end-to-end investigation process.


* Monitor action effectiveness and confirm root cause is eliminated or reduced to an acceptable level.


* Use data analytics and trending to identify failure modes, measure action effectiveness, and inform continuous improvement priorities.


* Compile and provide regular investigation and action 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 as needed.


* Partner with site investigation business process owners and 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 investigation review meetings, as needed.


* Perform other duties as necessary.

DECISION-MAKING AND PROBLEM-SOLVING:


* Ability ...