GMP Auditor, QA Compliance

Role Summary

This position is responsible for cGMP auditing and supplier management activities at Artiva.

Responsibilities

• Perform GMP/GDP audits in accordance with the external and internal audit program.
• Support GXP audits (GLP, GCP, GCLP), as necessary.
• Perform Drop-In GMP Internal audits.
• Create and maintain audit schedules.
• Track audit responses to completion.
• Oversee and maintain the supplier qualification program.
• Support the creation and execution of Quality Agreements with suppliers.
• Update databases, prepare metrics, identify and communicate trending and tracking of audits and related supplier management activities.
• Support audits by regulatory or state agencies and partners.
• Support QA review of Analytical Development and Process Development data and reports, as needed.
• Follow applicable regulations, including FDA, ISO, ICH, company policies and procedures.
• Support other QA department needs as identified by management.

Qualifications

• Required: Bachelor’s degree or a combination of relevant education and applicable job experience
• Required: 5+ years’ experience in an FDA regulated industry and expert knowledge of CGMP regulations
• Preferred: Certified Quality Auditor credential
• Required: Ability to adapt quickly to shifting needs and/or priorities
• Required: Able to interface well with all levels of personnel
• Required: Excellent communications skills, both written and verbal and a high degree of professionalism
• Required: Exceptional attention to detail
• Required: Flexibility to travel