Quality Assurance Specialist - GMP & Continuous Improvement

ACTalent; Eden Prairie (MN); On-site; USD 37,000 - 44,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Paid time off (PTO)

Job summary

Actalent seeks a Quality Specialist to audit the Eden Prairie facility and production lines, evaluate raw materials, bulk, and finished products, and drive continuous improvement in a world-class manufacturing control program.

The role supports quality across the organization, ensuring deviations and OOS are investigated, documented, and resolved. Requires GMP experience and a solid understanding of cGMP regulations; onsite work in Eden Prairie, MN.

Qualifications

• 2+ years in GMP manufacturing (pharma/cosmetics/food/device) preferred.
• HS Diploma required; Associate or Bachelor's degree preferred.
• Working knowledge of cGMP and 21 CFR regulations.

Responsibilities

• Complete packaging batch record paperwork accurately and timely.
• Audit manufacturing lines and plant to maintain a strong control program.
• Document, escalate, and resolve quality events to support decisions.
• Maintain SOPs, work instructions, and test procedures.
• Update SOPs and forms to support improvements and compliance.
• Ensure records comply with current GMP requirements.
• Investigate deviations and OOS, determine root causes, propose CAPAs.
• Coach personnel on regulatory and quality requirements.
• Verify products meet quality specs before release.
• Maintain current reference/production standards and updates.
• Record data per cGMP; align with regulatory expectations.

Skills

GMP Manufacturing

Quality auditing

Deviation investigation

Regulatory knowledge

Education

HS Diploma

Associate/Bachelor preferred

Job description

Actalent seeks a Quality Specialist to audit the Eden Prairie facility and production lines, evaluate raw materials, bulk, and finished products, and drive continuous improvement in a world-class manufacturing control program.

The role supports quality across the organization, ensuring deviations and OOS are investigated, documented, and resolved. Requires GMP experience and a solid understanding of cGMP regulations; onsite work in Eden Prairie, MN.