Audit Program Specialist

2 months ago


Scottsdale, Arizona, United States West Pharmaceutical Services Full time
Job Summary

We are seeking a highly skilled Audit Program Specialist to join our team at West Pharmaceutical Services. In this role, you will play a critical part in supporting our external and internal audit programs for a medical device manufacturing facility.

Key Responsibilities
  • Maintain the internal and external audit schedule, ensuring timely completion of audits and coordination with customers and regulatory bodies.
  • Prepare the site for audits, ensuring all necessary documents are in order and the facility is audit-ready.
  • Act as audit host, providing site visitor presentations and conducting facility tours with auditors.
  • Receive and respond to audit reports, working with management and technical staff to implement corrective and preventive actions.
  • Coordinate with observation owners to ensure timely completion of audit corrections.
  • Host near-miss meetings with site SMEs to prevent future findings.
  • Provide training to site employees on regulatory and ISO standards, as needed.
  • Maintain audit databases and ensure they are up-to-date.
  • Monitor and track audit metrics, ensuring compliance with internal requirements.
  • Utilize knowledge of International Standards and Federal Regulations to maintain the quality management system.
Requirements
  • Strong analytical thinking and complex problem-solving skills.
  • Bachelor's degree in engineering or similar degree, or equivalent work experience.
  • ISO 13485 Lead Auditor certification.
  • Experience working within FDA CFRs, ISO 13485, EU MDR, or other regulated environments.
  • Experience completing CAPAs and/or complex investigations.
Preferred Qualifications
  • EU MDR auditor certification.
  • CQA/ASQ certification.
  • Ability to interface with customers and meet customer expectations.
  • Experience operating within the Medical Device regulations.
  • Ability to work with interdisciplinary teams.
  • Experience with Project Management tools and ability to provide support and contribute in Lean Sigma programs and activities.
Travel Requirements

No travel required.

Physical and Mental Requirements
  • Ability to work in an office and/or manufacturing environment.
  • Need to have extreme attention to detail.


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