Senior Specialist Quality Assurance Auditor

Posted 11 Days Ago
Be an Early Applicant
4 Locations
In-Office or Remote
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Responsible for planning, conducting, and reporting R&D Quality Assurance audits to ensure compliance with corporate and regulatory standards. Also supports inspections and trains team members.
Summary Generated by Built In

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.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Bangkok, Bangkok, Thailand, Jakarta, Indonesia, Petaling Jaya, Selangor, Malaysia, Singapore, Singapore

Job Description:

Main responsibilities will include, but are not limited to:

Auditing

  • Independently leads the planning, conduct, reporting of R&D Quality QA routine and non-routine audits/assessments/inspections of activities, data, internal facilities and processes in GxP to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements.   Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.  Manages complex or business critical audits/issues in a supporting or leading role.  May support other auditors in planning, conduct and reporting of audits. 

  • Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.

Inspection Support

  • Participates in regulatory inspections in core and supporting roles

Training & Development

  • Assists in preparation and delivery of training materials. Advises and contributes to coaching

  • Completes training requirements in a timely manner to ensure inspection readiness at all times.

Project Management

  • Takes an active role in projects as assigned by supervisor and interacts with key stakeholders as appropriate.

  • Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress.

Expertise

  • Provides expertise and knowledge to less experienced auditors, Business Partners and the core business sector on quality and compliance processes/procedures. Interprets and applies regulations/ policies to issues of moderate complexity, when required.



Required Skills:



Preferred Skills:

Business Alignment, Coaching, Collaborating, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility

Skills Required

  • Experience in auditing compliance
  • Knowledge of regulatory requirements
  • Expertise in Good Manufacturing Practices

Johnson & Johnson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.

  • Healthcare Strength Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
  • Retirement Support Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
  • Parental & Family Support Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.

Johnson & Johnson Insights

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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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