Job Description

PCI Pharma Services seeks a QA Specialist II to oversee supplier qualification and compliance programs across GMP operations. The role involves conducting supplier audits, managing audit observations, tracking non-conformances, and ensuring adherence to regulatory standards in a pharmaceutical manufacturing environment.

Responsibilities

• Schedule and conduct supplier audits to evaluate compliance with SOPs, quality and regulatory standards
• Track supplier audit observations to closure and review responses for non-recurrence of deficiencies
• Monitor, communicate, and reconcile supplier change notifications, non-conformances, and complaints
• Draft, review, and manage supplier quality agreements and NDAs
• Request, reconcile, and maintain supplier qualification documentation and KPI metrics

Requirements

• Bachelor of Science degree with 5+ years QA GMP experience, or High School diploma with 10+ years progressive QA GMP experience
• Knowledge of FDA 21CFR Parts 210, 211, 820 and EMA/ICH regulatory guidance
• Proficiency in MS Office (Word, Excel, Access, Visio)
• Experience in pharmaceutical, biotech, or medical device GMP quality systems
• Exceptional organizational and interpersonal skills with strong written and oral communication
• Ability to work independently in complex, regulated environments and travel 10-20%

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