Senior Supplier Quality Auditor – GMP & FDA Focus

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

PCI Pharma Services in Bedford, NH is seeking a Senior QA Specialist – Supplier Quality to join the Quality Assurance team. You will oversee supplier qualification, conduct audits, report findings and ensure compliance with FDA regulations across PCI facilities.

This role requires extensive QA GMP experience, strong communication skills, and the ability to work independently while coordinating with cross-functional teams to maintain high quality standards.

Qualifikationen

• Bachelor of Science in QA/related field preferred with 15+ years in a QA GMP environment.
• Master's Degree with 10+ years in QA GMP is acceptable.
• High School diploma with 20+ years' QA GMP experience also acceptable.

Aufgaben

• Perform supplier audits to evaluate compliance with SOPs, quality and regulatory standards and issue audit reports.
• Track supplier audit observations to ensure timely closure.
• Monitor supplier change notifications and manage supplier non-conformance and complaints.

Kenntnisse

QA GMP experience

Audit coordination

Regulatory knowledge

Cross-functional teamwork

MS Office

Ausbildung

Bachelor of Science in QA/related

Master's Degree in QA/related

High School Diploma with QA experience

Tools

MS Office Suite

Jobbeschreibung

PCI Pharma Services in Bedford, NH is seeking a Senior QA Specialist – Supplier Quality to join the Quality Assurance team. You will oversee supplier qualification, conduct audits, report findings and ensure compliance with FDA regulations across PCI facilities.

This role requires extensive QA GMP experience, strong communication skills, and the ability to work independently while coordinating with cross-functional teams to maintain high quality standards.