Onsite Quality Assurance Auditor: GMP Floor & CAPA Lead

Actalent; Madison (WI); On-site; USD 62,000 - 72,000; Full time

Benefits offered by this job

Medical, Dental and Vision on day 1

401k with company match

Vacation and sick time

Job summary

Actalent is seeking a Quality Assurance Auditor for an on‑site role in Madison, WI. The position involves on‑floor verifications, mini audits, and review of critical documents to ensure regulatory compliance, with a mix of documentation review and reporting in an EQMS environment.

The role requires 0–2+ years in a regulated setting, a science degree, and flexibility for 12‑hour rotating shifts. Benefits include medical/dental/vision and a 401k plan.

Qualifications

• Bachelor’s degree in any science discipline preferred.
• Experience in pharmaceutical manufacturing or a similar regulated production environment preferred.
• Familiarity with FDA regulations and pharmaceutical quality systems preferred.
• 0–2+ years of experience in a regulated industry environment such as GMP, FDA, or ISO-regulated operations.
• Experience or familiarity with batch records, batch record review, and document control practices.
• Ability to work 12‑hour shifts on a rotating schedule, including overnight hours for third shift.

Responsibilities

• Spend approximately 60–70% of working time on the production floor supporting operations and verifying that activities comply with established procedures and quality standards.
• Conduct routine walkthroughs of production areas to observe operations, identify potential issues, and ensure processes occur as intended.
• Perform onsite reviews and mini audits to confirm adherence to GMP, FDA, ISO, and internal quality requirements.
• Collaborate with operations personnel to identify problems, propose solutions, and help initiate deviations when necessary.
• Review executed batch records, cleaning records, logbooks, and other quality‑related documents for accuracy, completeness, and compliance.
• Issue batch records as needed to support production activities and ensure proper documentation is in place before manufacturing.
• Document findings from floor walkthroughs, reviews, and audits, and report observations to appropriate stakeholders in a clear and timely manner.
• Support CAPA and document control activities related to quality events, deviations, and audit findings, as needed.
• Follow area‑specific gowning and safety requirements, ranging from safety shoes to full gowning, depending on the production area.
• Use electronic quality management systems (EQMS) and other office tools to manage documentation, track activities, and maintain records.

Education

Bachelor’s degree in any science discipline

Tools

EQMS

Job description

Actalent is seeking a Quality Assurance Auditor for an on‑site role in Madison, WI. The position involves on‑floor verifications, mini audits, and review of critical documents to ensure regulatory compliance, with a mix of documentation review and reporting in an EQMS environment.

The role requires 0–2+ years in a regulated setting, a science degree, and flexibility for 12‑hour rotating shifts. Benefits include medical/dental/vision and a 401k plan.