QA Analyst — First Shift, GMP Manufacturing Quality

Trustapexinternational; Eden Prairie (MN); On-site; USD 34,000 - 39,000; Full time

Benefits offered by this job

Medical, Rx, Dental, Vision benefits

Disability insurance

Life Insurance and AD&D

401(k) with company match

Employee Assistance Program

Job summary

Apex International is seeking a QA Analyst on the 1st Shift in Eden Prairie, MN. The role will ensure product quality and regulatory compliance through batch record review, investigations, and continuous improvement within a regulated manufacturing setting.

The analyst will train personnel on quality systems, support lean and 5S efforts, and assist with SOP updates while coordinating work with production and QA teams.

Qualifications

• Minimum 2 years in GMP manufacturing or regulated environment.
• Bachelor's degree in Chemistry, Biology, or related field preferred; equivalent experience considered.
• Working knowledge of cGMP regulations and 21 CFR requirements.

Responsibilities

• Review batch records to ensure quality and compliance.
• Audit documentation and ensure GDP, cGMP, SOPs, and testing procedures are followed.
• Perform product release approvals and maintain specifications.

Skills

GMP

Regulatory compliance

Documentation

Root cause analysis

Lean

5S

Quality assurance

Education

Bachelor's degree in Chemistry or Biology

Tools

Microsoft Office

Job description

Apex International is seeking a QA Analyst on the 1st Shift in Eden Prairie, MN. The role will ensure product quality and regulatory compliance through batch record review, investigations, and continuous improvement within a regulated manufacturing setting.

The analyst will train personnel on quality systems, support lean and 5S efforts, and assist with SOP updates while coordinating work with production and QA teams.