Quality Auditor ISO 9001

Reposted 18 Days Ago
Be an Early Applicant
Hiring Remotely in Akron, OH, USA
In-Office or Remote
Senior level
Pharmaceutical
The Role
Conduct audits to ensure compliance with ISO standards, develop audit plans, assess client facilities, and identify areas for improvement while maintaining positive client relationships.
Summary Generated by Built In

The Quality Assessments Division of Smithers seeks full-time Auditors to join our ISO Sector team. If you want to be a part of our mission to provide our clients with accurate data, on-time with high-touch, 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, environmental and occupational, health and safety management systems. Your goal is to build positive relationships with our customers while providing quality auditing and exceptional client service.

Duties:

  • Conducting audits to assess compliance with ISO standards.
  • Development and execution of audit plans and reports.
  • Assess 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 Accidental death and dismemberment (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.

Top Skills

Business Operation System (Bos)
Iso 14001
Iso 45001
Iso 9001
Sqa Audit Management Platform
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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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