Sr Anlst Quality Assurance

Johnson & Johnson•Raritan, NJ

10h•Onsite

About The Position

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. The Sr. Quality Specialist will also execute quality reviewer/approver duties, review evidence, and approve closure of investigation records. They will conduct investigation record quality reviews for documentation completeness, robust root-cause analysis, and compliance with procedures. Additionally, they will provide coaching and actionable feedback to issue owners on best practices, system usage, and investigation execution. The role involves facilitating the progression of investigations and related actions, monitoring progress and approvals, and collaborating with key stakeholders to support the end-to-end investigation process. This includes monitoring action effectiveness and confirming root cause is eliminated or reduced to an acceptable level. The Sr. Quality Specialist will use data analytics and trending to identify failure modes, measure action effectiveness, and inform continuous improvement priorities. They will compile and provide regular investigation and action status updates, metric reports, and trending analyses. Collaboration with stakeholders, site owners, governance bodies, and senior management is crucial for resolving issues and aligning on corrective actions, with escalation of risks or compliance issues as needed. The role also involves partnering with site investigation business process owners to sustain processes and support platform enhancement requests, and participating in or supporting internal audits and regulatory inspections. Attending, participating, and/or facilitating investigation review meetings are also part of the responsibilities.

Requirements

Bachelor’s Degree or equivalent is required.
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.
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.
Strong attention to detail, excellent time management, relationship-building, and experience with CAPA systems, investigative techniques, and data-driven quality improvement.

Nice To Haves

Life Science or related discipline is preferred.

Responsibilities

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.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (or 48/56 hours depending on state)
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year