Supplier Quality Auditor

Supplier Quality Auditor

Job Description

The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for the client's company. The Supplier Quality Auditor will conduct external supplier/vendor manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites.

Ideal candidates will have an external auditing background in medical devices and pharmaceutical working in the manufacturing industry.

Responsibilities

Develop and maintain a risk-based external auditing program for client company harmonized across all sites.

Prepare external audit schedules and conduct audits per the schedule

Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs

In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs) Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs), and Data Integrity principles.

Qualifications

Bachelor's degree in chemistry, biological sciences, engineering, or life sciences.

5 - 8 years experience in quality systems auditing in pharmaceutical, biologics, or medical device industry.

Certified Auditor or Lead Auditor credentials required

Experienced with auditing raw materials/excipients, components, and analytical and micro laboratories

EU and PMDA regulations knowledge and associated guidelines

Travel required up to 50%

Must be a U.S. Citizen, or Greencard holder

No Relocation for this role

Perks

Supportive and creative work environment

All travel expenses paid