QA Specialist I — GMP Supplier Quality & Compliance

PCI Pharma Services; Bedford (NH); On-site; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services seeks a QA professional to manage supplier quality for GMP operations. The role ensures the Supplier Qualification program is executed across PCI facilities, handling audits, change control, and QA agreements.

You will collaborate with cross-functional teams, review audit responses, and support supplier risk assessments while maintaining compliance with FDA/EMA guidelines. This position is on-site in New Hampshire with travel <10%.

Qualifications

• Bachelor of Science preferred with 3+ years in a QA GMP environment; High School diploma with 5+ years of progressive QA GMP experience considered.
• Strong organizational and interpersonal skills with clear written and verbal communication.
• Familiarity with GMP quality systems and regulatory guidance (FDA 21 CFR Part 210, 211; EMA) and ICH is preferred.

Responsibilities

• Oversee follow up and tracking of supplier audit observations to ensure timely closure.
• Monitor supplier change notifications and manage supplier non-conformance and complaint handling.
• Review audit responses to ensure non-recurrence of deficiencies.
• Draft, review and manage supplier quality assurance agreements and NDAs.
• Collaborate with Corporate Supplier Quality team; report status of site-specific actions.

Skills

QA GMP

MS Office

Cross-functional

Regulatory guidance

Education

Bachelor of Science

Tools

MS Office

Job description

PCI Pharma Services seeks a QA professional to manage supplier quality for GMP operations. The role ensures the Supplier Qualification program is executed across PCI facilities, handling audits, change control, and QA agreements.

You will collaborate with cross-functional teams, review audit responses, and support supplier risk assessments while maintaining compliance with FDA/EMA guidelines. This position is on-site in New Hampshire with travel <10%.