QA Operations Associate I — GMP Floor

PCI Pharma Services; Madison (WI); On-site; USD 55,000 - 75,000; Full time

Job summary

PCI Pharma Services in Madison, WI is seeking a QA Associate I - Operations to provide real-time QA support on the floor during GMP manufacturing, overseeing critical processes and ensuring compliant documentation. This role reports to the QA Operations Supervisor and sits in Quality Assurance.

The position entails on-the-floor audits, batch record review, deviation handling, and participation in CAPA activities, with opportunities to drive process improvements and compliance across projects.

Qualifications

• Bachelor's degree in a scientific discipline; pharma/biotech experience helpful.
• Experience with RCA, technical writing, and quality investigations.
• Lean operation excellence knowledge is desirable.
• Familiarity with FDA regulations (21 CFR 210, 211, 820) and ICH guidelines.
• Understanding of risk management tools (FMEA, HACCP, PHA) preferred.
• ASQ certification is a plus.

Responsibilities

• Provide on-the-floor QA support for GMP manufacturing and room release.
• Audit critical processes, review documents in real time, and resolve issues.
• Review batch records for completeness, accuracy and compliance.
• Support lot disposition of intermediates and drug product.
• Act as first responder for quality issues and document investigations.
• Participate in root cause analysis using standard methodologies.
• Review deviations and CAPA with designated QA approvals.
• Perform AQL visual inspections and contribute to SOP revisions.
• Contribute to site quality initiatives and cross-functional projects.

Skills

RCA

Technical writing

Lean operation

FDA regulations

ICH guidelines

Risk management tools

ASQ certification

Education

Bachelor's Degree in a relevant scientific discipline

Tools

FMEA

HACCP

PHA

Job description

PCI Pharma Services in Madison, WI is seeking a QA Associate I - Operations to provide real-time QA support on the floor during GMP manufacturing, overseeing critical processes and ensuring compliant documentation. This role reports to the QA Operations Supervisor and sits in Quality Assurance.

The position entails on-the-floor audits, batch record review, deviation handling, and participation in CAPA activities, with opportunities to drive process improvements and compliance across projects.