Description

**Please note that this is a part-time temporary/consultant position. Need is for 24 hours a week, 2 days a week expected to work onsite.

Position Summary

The GMP Auditor/Consultant is responsible for planning and conducting quality audits (Quality auditing oversight) related to GMP vendors and for qualifying vendors. This role will facilitate upcoming audits, support the development and revision to Quality Agreements and provide support for the supplier qualification program. 

Responsibilities 

These may include but are not limited to:

• Lead vendor and internal audits, conducting the audit planning and scheduling, audit scope development and execution of the audit including opening/closing activities and report preparation
• Schedule, prepare, and conduct Vendor Qualification
• Perform audits in accordance with Poseida standard operating procedures and regulatory requirements
• Communicating audit results to management and auditees through written audit reports
• Leading post-audit activities, assess audit findings and assist the business in identifying and developing CAPAs/ remediation options and prioritize their closure
• Updating Vendor Audit list including approved vendors
• Working with Poseida cross functional teams in identifying new vendors that require qualification and or audit activities
• Coordinating activities in support of the Vendor audit plan 
• Other QMS/Compliance functions as assigned.

Requirements

 Qualifications: 

• Minimum 8 years GMP auditing experience including raw material suppliers, third party service providers.
• Direct auditing experience required.
• Supplier quality management program experience required and QA/Compliance experience required.
• ASQ audit certification preferred.
• Limited travel required for audits.