QA Specialist I — Drive Compliance in Biotech Manufacturing

PCI Pharma Services; Madison (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

PCI Pharma Services is seeking a QA Specialist to ensure product quality and compliance with cGMPs, site SOPs, and regulatory standards. You will review batch records, master batch records, and manage deviations, CAPAs, and quality system investigations for clinical and commercial products.

The role requires 3–5 years in pharma/biotech QA, familiarity with 21 CFR 820, and strong documentation skills. Collaborative cross-functional work and process improvements are key aspects.

Qualifications

• Bachelor's Degree in a relevant scientific field.
• 3-5 years of pharmaceutical or biotech industry experience.
• 2+ years in a QA Operations role supporting late-stage clinical or commercial production.
• Knowledge of FDA regulations (21 CFR Part 820).
• Experience with deviation investigations, CAPA and quality investigations.
• Exposure to lean operation excellence.
• Knowledge of risk management tools (FMEA, PHA, etc.).
• Ability to articulate complex scientific/technical subject matter.
• ASQ certification is preferred.

Responsibilities

• Perform batch documentation review for release of clinical and commercial products with cGMP, site SOPs, and regulatory compliance.
• Review/approve master batch records to initiate GxP manufacturing activities.
• Oversee deviation/investigation and CAPA programs and provide direction on complex investigations.
• Review and approve investigations in support of batch release and GMP compliance.
• Track investigations and change controls; provide status reports and metrics.
• Develop and improve quality system procedures, specs, and test methods.
• Collaborate with internal/external customers to resolve quality and compliance issues.

Job description

PCI Pharma Services is seeking a QA Specialist to ensure product quality and compliance with cGMPs, site SOPs, and regulatory standards. You will review batch records, master batch records, and manage deviations, CAPAs, and quality system investigations for clinical and commercial products.

The role requires 3–5 years in pharma/biotech QA, familiarity with 21 CFR 820, and strong documentation skills. Collaborative cross-functional work and process improvements are key aspects.