GMP Quality Auditor & Process Coach — 3rd Shift

Apex-International; Eden Prairie (MN); On-site; USD 36,000 - 41,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Short-term disability

Long-term disability

Life Insurance

401(k) with company match

Employee assistance program

Job summary

Apex International is seeking a Quality Operations Technician to join our Eden Prairie, MN team. This on-site, full-time role audits manufacturing operations, evaluates materials, and supports quality and continuous improvement in a GMP environment.

The ideal candidate is detail-oriented, organized, and committed to building a culture of quality while supporting world-class manufacturing operations. Shift is 3rd, with potential overtime based on production needs.

Qualifications

• Knowledge of cGMP and 21 CFR manufacturing regulations.
• Strong organizational, multitasking, and problem-solving skills.
• Excellent interpersonal and coaching abilities; proficient in Microsoft Office.

Responsibilities

• Audit manufacturing lines and facility operations for GMP compliance.
• Complete packaging batch records and quality documentation.
• Document, investigate, and elevate deviations and OOS situations.
• Ensure compliance with SOPs, work instructions, test procedures, and regulatory requirements.
• Support SOPs, forms, and test method improvements.
• Maintain documentation in line with GMP requirements.
• Provide training and coaching to manufacturing personnel.
• Promote a culture of quality throughout the facility.
• Verify products meet specifications prior to release.
• Record and analyze quality data to identify trends and recurring issues.
• Participate in root cause investigations and corrective actions.

Skills

GMP knowledge

Attention to detail

Organizational skills

Communication skills

Reading & following instructions

Education

Bachelor's degree in Chemistry, Biology, or related science

Tools

Microsoft Office

Job description

Apex International is seeking a Quality Operations Technician to join our Eden Prairie, MN team. This on-site, full-time role audits manufacturing operations, evaluates materials, and supports quality and continuous improvement in a GMP environment.

The ideal candidate is detail-oriented, organized, and committed to building a culture of quality while supporting world-class manufacturing operations. Shift is 3rd, with potential overtime based on production needs.