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New · posted Oct 16

Johnson & Johnson · Pharmaceuticals

Sr Analyst Quality Assurance

  • Raritan, NJ
  • On-site
  • Full-time
  • Senior & Principal
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EmploymentFull-time
Deadline

Closes Oct 22, 2026 · 7 days left

The role

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.

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 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.

DECISION-MAKING AND PROBLEM-SOLVING

  • Ability to work independently and coordinate across functional areas driving compliance to the Investigation 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.

  • Investigation team members – interfaces daily as needed to manage workload, interfaces weekly in team meetings.

  • Business functions involved in owning investigations and delivering action commitments - interfaces as needed to address identified issues and provide guidance on established processes.

What you need

EDUCATION & EXPERIENCE REQUIREMENTS

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

  • 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.

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

Preferred Skillsnice to have

Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

Pay and benefits

$94,000 – $151,800 a year

Employer provided
How this compares

The anticipated base pay range for this position is

$94,000.00 - $151,800.00

  • Retirement plan (pension) and 401(k) savings plan

  • Long-term incentive program eligibility

  • Vacation (120 hours per year)

  • Sick time (40 hours per year)

  • 13 paid holidays per year

  • Parental leave (480 hours)

Where you'll work

Raritan, NJOn-siteOpen in Maps (opens in a new tab)

More jobs in Raritan, NJ

Working conditions

Job Function

Quality

Job Sub Function

Quality Assurance

Job Category

Professional

All Job Posting Locations

Raritan, New Jersey, United States of America

Equal opportunity, accessibility and legal noticesJohnson & Johnson's statements, word for word

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

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 period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

Job intelligence

The context around this role

Live data · October 16, 2026

Salary intelligence

How the pay compares

This role's midpoint is level with the US median for Quality Assurance roles at this level.

This roleEmployer provided

$94,000 to $151,800 a year

Senior & Principal roles in New Jersey13 roles publishing pay

Middle half $102,500 to $143,000, median $123,000

Senior & Principal roles in the US285 roles publishing pay

Middle half $104,000 to $137,500, median $122,500
Annual base pay
Annual base payLowMedianHigh
This role$94,000—$151,800
New Jersey$102,500$123,000$143,000
All US$104,000$122,500$137,500

This role: Johnson & Johnson's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 16, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Quality Assurance

The general path across 866 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Johnson & Johnson's own promotion track.

  1. One step back

    Associate & Specialist

    Often: Quality Engineer · Quality Technician

    $79K median239 open
  2. This role

    Senior & Principal

    Often: Quality Engineer · Senior Quality Engineer

    $123K median359 open
  3. Next step

    Manager

    Often: Manager, Quality Assurance · Quality Manager

    $154K median137 open
  4. Later

    Director

    Often: Director, Quality · Associate Director, Quality Assurance

    $209K median115 open
  5. Later

    VP & Executive

    Often: Vice President, Quality Assurance · AVP

    $306K median16 open

Skills DNA

What this role leans on

How many of the posting's 39 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 7 linesLab testing and methods: 2 linesDocumentation and SOPs: 7 linesInvestigations and CAPA: 18 linesQuality systems and risk: 4 linesData and digital systems: 1 lineCollaboration and leadership: 14 linesGMPLab testingDocumentationInvestigationsQuality systemsData systemsTeamwork
  • Investigations and CAPA18
  • Collaboration and leadership14
  • GMP and compliance7
  • Documentation and SOPs7
  • Quality systems and risk4
  • Lab testing and methods2
  • Data and digital systems1

Company hiring pulse

Johnson & Johnson on Regulatory Jobs

44
Open roles
44
Distinct roles
18
Locations

By discipline

  • Quality27 61%
  • Regulatory11 25%
  • Compliance & Safety6 14%

By level

  • Senior & Principal14 32%
  • Manager12 27%
  • Associate & Specialist10 23%
See all 44 Johnson & Johnson roles

More roles at Johnson & Johnson

All 44 Johnson & Johnson roles

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