Senior QA Specialist – Supplier Quality & Compliance

PCI Pharma Services; Bedford (NH); On-site; USD 120,000 - 180,000; Full time

Job summary

PCI Pharma Services in Bedford, NH is seeking a Sr. QA Specialist – Supplier Quality to lead supplier qualification activities across PCI facilities, including audits, follow-up on observations, and management of QA agreements.

The role requires extensive QA GMP experience, strong writing and communication skills, and proficiency with MS Office. A BS with 15+ years (or MS with 10+ years) in QA GMP is preferred, with regulatory knowledge.

Qualifications

• Bachelor/Master level QA GMP experience required or equivalent
• Excellent organizational and written communication skills
• Experience with GMP quality systems and FDA/ICH regulations

Responsibilities

• Perform supplier audits to evaluate compliance with SOPs, quality, and regulatory standards
• Track audit observations and ensure timely closure
• Monitor supplier change notifications and manage non-conformances and complaints
• Review audit responses to prevent recurrence of deficiencies
• Maintain and report quality metrics related to supplier audits and performance
• Draft and manage supplier quality agreements and non-disclosure agreements
• Support Quality Council meetings and regulatory inspections
• Develop and revise QA SOPs and participate in continuous improvement

Skills

Organizational skills

Interpersonal skills

MS Office

Communication skills

Education

BS in science (QA GMP)

MS in science (QA GMP)

High School diploma + 20+ yrs QA GMP

Tools

MS Office Suite (Word, Excel, Access, Visio)

Job description

PCI Pharma Services in Bedford, NH is seeking a Sr. QA Specialist – Supplier Quality to lead supplier qualification activities across PCI facilities, including audits, follow-up on observations, and management of QA agreements.

The role requires extensive QA GMP experience, strong writing and communication skills, and proficiency with MS Office. A BS with 15+ years (or MS with 10+ years) in QA GMP is preferred, with regulatory knowledge.