Quality Auditor ISO 9001

Posted 2 Days Ago
Be an Early Applicant
Hiring Remotely in Fairlawn, OH, USA
In-Office or Remote
Senior level
Pharmaceutical
The Role
Conduct ISO audits (quality, environmental, OHS), develop and execute audit plans, assess facilities and documentation, identify non-conformities and improvement opportunities, maintain records and auditor credentials, submit audit documentation and expense reports, and support clients through certification using BOS audit management platform.
Summary Generated by Built In

The Quality Assessments Division of Smithers seeks full-time Auditors to join our ISO sector audit team. If you want to be a part of our mission to help our clients innovate confidently in their development, production, and launch of new products and materials, we'd love to have you on board.

As an ISO Auditor, you will support clients through their certification process and assessment activities to verify conformance to management system standards focusing on quality management, environmental management, and occupational health and safety management. Your goal is to build positive relationships with our customers while providing quality auditing and exceptional support services.

Duties:

  • Conducting audits to assess compliance with ISO standards.
  • Development and execution of audit plans.
  • Assessing client facilities to determine conformity.
  • Evaluating documentation, processes, and procedures.
  • Identify non-conformities and areas of improvement.
  • Maintenance of appropriate records.
  • Submit expense reports and other critical audit documentation.
  • Maintain acquired auditor credentials.

Qualifications:

  • QMS, EMS, or OHSMS auditors must have five (5) years of work experience with a minimum of two (2) out of those five (5) years in quality, environmental, or occupational health and safety roles.
  • ISO 9001 / 14001 / 45001 Lead Auditor Certification.

Why Smithers?

  • Variable salary commensurate with experience and work efficiency
  • Medical, dental, and vision benefit plan
  • 401(k) retirement savings plan
  • Life insurance and AD&D
  • Short-term and long-term disability coverage
  • Wellness Program
  • Employee Assistance Program (EAP)
  • Business Operation System (BOS) – SQA Audit Management Platform
  • Training and development support
  • Flexible work schedule
  • Assignment priority
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Skills Required

  • Five (5) years of work experience with a minimum of two (2) years in quality, environmental, or occupational health and safety roles
  • ISO 9001 / 14001 / 45001 Lead Auditor Certification
  • Maintain acquired auditor credentials
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The Company
HQ: Akron, OH
783 Employees
Year Founded: 2005

What We Do

Our team helps medical device and pharmaceutical product manufacturers bring innovative, compliant and highly effective products to market with world-class expertise and extensive, independent testing capabilities at accredited facilities in the UK and USA. Our experienced medical device and extractables and leachables (E&L) testing teams will provide advice, guidance and recommendations as well as delivering test data to help you demonstrate compliance to regulatory guidance or specifications set out by the FDA, EMA, MHRA, USP, ASTM and ISO. Smithers also supports the pharmaceutical industry and the development of biologics and vaccines from discovery through phase IV, with expertise that includes bioassays and high sensitivity assays. Our scientists have expertise in large molecule bioanalysis assay development, validation, and sample analysis.

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