QA Specialist, I

PCI Pharma Services · Bedford, NH

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QualityFull-timeCompany career page

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Role summary

QA Specialist I will oversee batch record reviews, lot disposition, and quality system administration for clinical and commercial pharmaceutical products. The role involves deviation management, investigation oversight, CAPA coordination, and cross-functional collaboration to ensure cGMP compliance and regulatory standards at a Bedford, NH facility.

What they're looking for

Root cause analysis, technical writing, and quality investigation experience
Knowledge of laboratory/production equipment and IQ/OQ/PQ protocols
FDA regulations expertise (21 CFR Parts 210, 211, 820) and ICH familiarity
Risk management tools proficiency (FMEA, HACCP, PHA) and ICH Q9 knowledge
Bachelor's degree in relevant science discipline; 5-7 years pharma/biotech experience; 3+ years QA operations supporting late-stage clinical/commercial production
MS Office proficiency (Word, Excel, Access, Visio) and excellent written/verbal communication
Strong organizational skills, risk-based decision-making ability, and self-directed work style

What you'll be doing

Review and approve batch documentation for clinical and commercial product release ensuring cGMP and regulatory compliance
Manage deviation, investigation, and CAPA programs including review, approval, and tracking for timely closure
Develop, review, and approve quality system procedures, specifications, test methods, and change control documentation
Lead quality improvement projects and serve as QA representative on cross-functional teams for tech transfer and process validation
Coordinate with internal and external stakeholders on compliance matters and regulatory inspection readiness

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Date posted2 days ago

Last source check1 day ago

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