GMP Quality Ops Technician (2nd 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

Rx benefits

Short/Long-term Disability

Life Insurance

FSA options

401(k) with company match

Employee Assistance Program

Shift differential

Job summary

Apex International in Eden Prairie, Minnesota is seeking a Quality Operations Technician to join our Quality team. This on-site role audits manufacturing lines, evaluates materials, and ensures products meet GMP and customer specifications, while driving continuous improvement in a fast-paced facility.

The ideal candidate is detail-oriented with strong organizational and coaching skills, capable of documenting issues, supporting CAPAs, and maintaining thorough quality records in a collaborative

Qualifications

• Working knowledge of cGMP and 21 CFR manufacturing regulations.
• Ability to read and follow written work instructions and specifications.
• Able to work effectively in a fast-paced manufacturing environment.

Responsibilities

• Perform audits of manufacturing lines and facility operations to ensure compliance with quality standards, procedures, and GMP requirements.
• Complete required packaging batch records and quality documentation.
• Document, investigate, and escalate deviations, non-conformances, potential quality issues, and out-of-specification (OOS) situations.
• Ensure compliance with SOPs, work instructions, test procedures, and regulatory requirements.
• Support the maintenance and improvement of SOPs, work instructions, controlled forms, and test methods.
• Maintain accurate documentation and records in accordance with GMP requirements.
• Provide technical guidance, process direction, training, and coaching to manufacturing personnel.
• Promote quality awareness and help foster a culture of quality throughout the facility.
• Verify products meet specifications and customer standards prior to release.
• Maintain product specifications, standards, and reference materials.
• Accurately record and analyze quality data to identify trends and resolve recurring issues.
• Participate in root cause investigations and support corrective actions to prevent recurrence.

Skills

GMP knowledge

Organizational skills

Communication skills

Microsoft Office

Read SOPs

Education

Bachelor's degree in Chemistry or Biology

Job description

Apex International in Eden Prairie, Minnesota is seeking a Quality Operations Technician to join our Quality team. This on-site role audits manufacturing lines, evaluates materials, and ensures products meet GMP and customer specifications, while driving continuous improvement in a fast-paced facility.

The ideal candidate is detail-oriented with strong organizational and coaching skills, capable of documenting issues, supporting CAPAs, and maintaining thorough quality records in a collaborative