QA Analyst - Onsite GMP, Audit & CI (First Shift)

Apex Consumer Products; Eden Prairie (MN); On-site; USD 71,635,000 - 80,231,000; Full time

Benefits offered by this job

Medical, Rx, Dental, Vision benefits

Short term & Long-term Disability

Life Insurance and AD&D

401(k) Retirement Plan with company m

Employee Assistance Program

Job summary

Apex International in Eden Prairie, MN is seeking a QA Analyst on 1st Shift to ensure product quality and regulatory compliance. The role involves auditing batch records, deviations handling, and supporting Lean improvements in a regulated manufacturing environment.

Responsibilities include training staff, maintaining documentation, and ensuring adherence to GDP, cGMP, SOPs, and 21 CFR requirements. On-site work with a competitive benefits package and hourly pay of $25–$28.

Qualifications

• Bachelor's degree in Chemistry, Biology, or related scientific field, or equivalent experience.
• Minimum 2 years of GMP manufacturing experience.
• Working knowledge of cGMP, 21 CFR requirements.
• Experience reviewing documentation and working within regulated quality systems.
• Proficient in Microsoft Office and general computer applications.
• Strong organizational, communication, coaching, and problem-solving skills.
• Fluency in English.

Responsibilities

• Ensure Quality & Regulatory Compliance.
• Review Production Batch Records for accuracy and compliance.
• Complete approvals to run and product release activities.
• Maintain current product specifications and related documentation.
• Investigate deviations, non-conformances, and OOS events.
• Support regulatory expectations and standards including 21 CFR and USP.
• Provide guidance and process support to manufacturing personnel.
• Train staff on quality systems and SOPs.
• Promote quality culture on the production floor.
• Drive continuous improvement using data and floor observations.
• Conduct root cause investigations and implement corrective actions.
• Apply Lean principles and reinforce 5S standards.

Skills

GMP experience

Documentation review

Quality compliance

Problem-solving

Communication skills

Education

Bachelor's degree in Chemistry/Biology or related scientific field

Tools

Microsoft Office

Job description

Apex International in Eden Prairie, MN is seeking a QA Analyst on 1st Shift to ensure product quality and regulatory compliance. The role involves auditing batch records, deviations handling, and supporting Lean improvements in a regulated manufacturing environment.

Responsibilities include training staff, maintaining documentation, and ensuring adherence to GDP, cGMP, SOPs, and 21 CFR requirements. On-site work with a competitive benefits package and hourly pay of $25–$28.