Quality Operations Specialist - GMP Compliance & Audits

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

Benefits offered by this job

Medical, Rx, Dental and vision

Short term & Long term Disability

Life Insurance

Flexible Spending Account

401(k) Retirement Plan with company is

Employee Assistance Program

Shift differential

Job summary

Apex International in Eden Prairie, MN is hiring a Quality Operations Technician to audit manufacturing operations, evaluate materials, and support continuous improvement in a GMP setting. You will work on the 2nd shift, collaborating with production to ensure products meet customer and regulatory standards.

The role emphasizes attention to detail, strong organizational skills, and a passion for quality in a fast-paced environment.

Qualifications

• Working knowledge of cGMP and 21 CFR manufacturing regulations.
• Strong organizational, multitasking, and problem-solving skills.
• Excellent interpersonal, communication, and coaching abilities.
• Ability to read and follow written work instructions and specifications.

Responsibilities

• Audit manufacturing lines and facility operations for GMP compliance.
• Complete packaging batch records and quality documentation.
• Document and investigate deviations, non-conformances, and OOS situations.
• Ensure adherence to SOPs, work instructions, and regulatory requirements.
• Support SOPs, work instructions, forms, and test method improvements.
• Maintain accurate GMP-compliant documentation and records.
• Provide guidance and training to manufacturing personnel.
• Promote a culture of quality throughout the facility.
• Verify products meet specifications before release.
• Record and analyze quality data to identify trends.
• Participate in root cause investigations and corrective actions.
• Support Lean, 5S, and waste reduction initiatives.

Skills

cGMP knowledge

Regulatory compliance

Documentation & record-keeping

Microsoft Office

SOP reading & adherence

Education

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

Tools

Microsoft Office

Job description

Apex International in Eden Prairie, MN is hiring a Quality Operations Technician to audit manufacturing operations, evaluate materials, and support continuous improvement in a GMP setting. You will work on the 2nd shift, collaborating with production to ensure products meet customer and regulatory standards.

The role emphasizes attention to detail, strong organizational skills, and a passion for quality in a fast-paced environment.