Quality Operations Technician, 1st Shift

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

About the Role

Apex International is seeking a Quality Operations Technician to join our Quality team in Eden Prairie, Minnesota. This is a full-time, on-site position responsible for auditing manufacturing operations, evaluating raw materials, bulk materials, and finished products, supporting quality and compliance activities, and driving continuous improvement efforts within a GMP manufacturing environment.

This role works closely with production personnel to ensure products meet customer expectations, regulatory requirements, and internal quality standards. The ideal candidate is detail-oriented, organized, and passionate about building a culture of quality while supporting world-class manufacturing operations.

Key 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 elevate 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
• Maintain compliance with current regulatory expectations and practices
• Support Lean initiatives, waste reduction efforts, and 5S activities within the department
• Perform additional duties as assigned

Qualifications

Required

• Working knowledge of cGMP and 21 CFR manufacturing regulations
• Strong organizational, multitasking, and problem-solving skills
• Strong interpersonal, communication, and coaching skills
• Proficiency with Microsoft Office
• Ability to read and follow written work instructions and specifications
• Ability to work effectively in a fast-paced manufacturing environment

Preferred

• Minimum of two years of experience in a GMP manufacturing environment such as pharmaceutical, cosmetics, personal care, food processing, or medical device manufacturing
• Bachelor's degree in Chemistry, Biology, or a related science discipline, or equivalent experience

Schedule

Shift: 1st Shift, Monday through Friday from 6:00AM - 2:00PM

This is an on-site position located in Eden Prairie, Minnesota. Additional hours beyond the regular work schedule may be required based on production demands, customer requirements, and business needs. Periodic overtime and weekend work may be necessary.

Benefits

• $26 - $30 per hour base pay depending on experience
• Medical, Rx, Dental and vision benefits
• Company paid Short term & Long-term Disability
• Company paid Life Insurance
• Optional Life Insurance for employee, spouse and children
• Flexible Spending Account options for child and health care
• 401(k) Retirement Plan with company match
• Employee Assistance Program