Audit Program Specialist
2 months ago
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.
- 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.
- 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.
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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