Onsite QA Specialist (Day Shift) – cGMP & CAPA Expert

ACTalent; Minnetonka (MN); On-site; USD 36,000 - 41,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

PTO / Vacation

Job summary

Actalent is seeking a Quality Assurance Specialist for a fully onsite, day-shift contract-to-hire role in Minnetonka, MN. You will review batch records, COAs, and documentation to ensure compliance with cGMP and internal quality standards before product release, contributing to product safety and regulatory readiness.

You will manage deviations, CAPAs, change controls, and investigations, support continuous improvement with Lean tools, and write quality documentation.

Qualifications

• 3+ years of quality experience in a cGMP manufacturing environment.
• Strong knowledge of cGMP, GDP, and quality documentation requirements.
• Hands-on experience with deviations, CAPAs, investigations, change controls, and batch record review.

Responsibilities

• Review batch records and supporting documentation for accuracy and compliance prior to final approval and product release.
• Verify calculations, specifications, and manufacturing data to meet internal quality standards and customer requirements.
• Prepare and review Certificates of Analysis (COAs) and other required quality and manufacturing documentation.
• Manage quality system activities including deviations, CAPAs, change controls, quality alerts, and annual product reviews.
• Support investigations related to deviations and quality events, ensuring proper documentation and justification.
• Support continuous improvement using Lean Manufacturing principles, 5S, and other Lean tools.
• Assist with writing deviations, investigations, and other quality documentation to support compliance.

Skills

Quality Systems Experience

cGMP Knowledge

Quality Documentation

Deviations & CAPAs Handling

Education

Bachelor's degree in a scientific discipline or related field

Job description

Actalent is seeking a Quality Assurance Specialist for a fully onsite, day-shift contract-to-hire role in Minnetonka, MN. You will review batch records, COAs, and documentation to ensure compliance with cGMP and internal quality standards before product release, contributing to product safety and regulatory readiness.

You will manage deviations, CAPAs, change controls, and investigations, support continuous improvement with Lean tools, and write quality documentation.