Sr. Supplier Quality Auditor; pharmaceutical

Senior Quality Auditor (Level II)

HTI and PAI Pharma are seeking a Senior Quality Auditor for their facility in Greenville, SC. PAI Pharma is a leader and manufacturer of liquid medications in the United States. The salary range for this position is around $80k annually, dependent upon experience.

* This position will require travel 50% to 75% of the time and requires a valid passport.*

• Full benefits package – Medical, Dental, Vision, EAP, 401k Match
• Onsite Wellness Center
• Tuition Reimbursement
• 13 Paid Holidays
• Progressive PTO Plan

• Bachelor of Science Degree required.
• Certified Quality Analyst preferred.
• Knowledge of GMP Documentation.
• Proficient in Microsoft Office Suite.

• Maintain current supplier qualification documentation (SAQs, Quality Agreements, Change Controls Assessments, Risk Evaluations, Audit Reports, CAPA responses).
• Maintain a comprehensive risk evaluation of suppliers and determine criticality based on risk assessment. Organize yearly audits or SAQ documentation accordingly.
• Travel and audit critical suppliers or those for cause.
• Promote cGMP/GDP compliance in an FDA‑regulated pharmaceutical manufacturing environment, ensuring product integrity, safety and compliance of suppliers.
• Apply auditing techniques to evaluate supplier compliance.
• Participate in site audits as part of a team for manufacturers of facilities that provide pharmaceutical ingredients, components, or contract manufacturing services.
• Apply knowledge of quality control/microbial techniques, data integrity, ALCOA, documentation interpretation, and investigations to support supplier quality.
• Provide technical expertise regarding in‑process contamination control.
• Evaluate audit data and lab work from CMO and supplier audits to assess compliance with ISO, GMP, Annex I, GLP and SOPs.
• Review records for accuracy, consistency and compliance with aseptic processes during audits or pre‑audit documentation.
• Review returned supplier qualification documents, verify readiness for final approval, and maintain final signatory documents in an accessible electronic location.
• Complete audit findings reports and submit them as part of the final audit closure (critical, major or minor) in a timely manner.
• Follow up on audits concerning investigations of non‑compliant issues until resolution is communicated.
• Gather information for PAI site departments regarding potential events with suppliers to support audit reviews.
• Maintain a current calendar of travel and audit schedule.
• If not traveling, maintain onsite presence at the Greenville facility.

Seniority Level: Mid‑Senior

Employment Type: Full‑time

Job Function: Accounting/Auditing, Quality Assurance, Analyst

Industry: Pharmaceutical Manufacturing