QA Specialist II, Supplier Quality & Compliance (GMP)

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 85,000 - 120,000; Full time

Job summary

PCI Pharma Services in New Hampshire seeks a QA professional to oversee supplier qualification for GMP operations. You will audit suppliers, track audit findings, and manage change notifications and non-conformances to ensure continuous quality.

The role supports KPI metrics, SOP development, and risk assessments, with 10–20% travel. A BS in science with 5+ years in QA GMP or a HS diploma with 10+ years is required.

Qualifications

• Bachelor of Science preferred with 5+ years in a QA GMP environment.
• High School diploma with 10+ years of QA GMP experience considered.
• Ability to articulate and comprehend industry related technical subject matter.
• Excellent organizational and written communication skills.

Responsibilities

• Audit suppliers for compliance with SOPs, quality and regulatory standards.
• Track supplier audit observations and ensure timely closure.
• Manage supplier change notifications, non-conformances, and complaints.
• Draft and manage supplier QA agreements and NDAs.
• Collaborate with Corporate Supplier Quality to align initiatives.

Skills

GMP QA experience

MS Office

Regulatory knowledge

Cross-functional teamwork

Communication skills

Education

Bachelor of Science

High School diploma

Tools

MS Office

Job description

PCI Pharma Services in New Hampshire seeks a QA professional to oversee supplier qualification for GMP operations. You will audit suppliers, track audit findings, and manage change notifications and non-conformances to ensure continuous quality.

The role supports KPI metrics, SOP development, and risk assessments, with 10–20% travel. A BS in science with 5+ years in QA GMP or a HS diploma with 10+ years is required.