GMP Quality Operations Technician (On-Site)

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

Benefits offered by this job

Medical, Rx, Dental and vision

Company paid Short term & Long-term DI

Company paid Life Insurance

Flexible Spending Account options

401(k) with company match

Employee Assistance Program

Job summary

Apex International is seeking a Quality Operations Technician in Eden Prairie, MN. This on-site role supports auditing manufacturing operations, evaluating materials, and driving continuous improvement in a GMP setting.

The ideal candidate will be detail-oriented, organized, and committed to fostering a culture of quality while supporting world-class manufacturing operations. Shift is 1st, with overtime as needed.

Qualifications

• GMP knowledge and 21 CFR familiarity required.
• Ability to read and follow written work instructions.
• Strong organizational, multitasking and problem-solving abilities.
• Effective communication and coaching skills.

Responsibilities

• Audit manufacturing lines and facilities for GMP compliance.
• Complete packaging batch records and quality documentation.
• Document, investigate and elevate deviations and OOS events.
• Maintain SOPs, work instructions, forms and test methods.
• Record and analyze quality data to identify trends.
• Provide training and coaching to manufacturing staff.
• Support Lean, 5S and waste reduction initiatives.
• Ensure products meet specifications prior to release.

Skills

GMP knowledge

CFR 21 compliance

Organizational skills

Communication

Problem-solving

Microsoft Office

Reading SOPs

Education

Bachelor's degree in related science

Equivalent GMP experience

Job description

Apex International is seeking a Quality Operations Technician in Eden Prairie, MN. This on-site role supports auditing manufacturing operations, evaluating materials, and driving continuous improvement in a GMP setting.

The ideal candidate will be detail-oriented, organized, and committed to fostering a culture of quality while supporting world-class manufacturing operations. Shift is 1st, with overtime as needed.