QA Analyst, 1st Shift

Trustapexinternational; Eden Prairie (MN); On-site; USD 34,000 - 39,000; Full time

Benefits offered by this job

Medical, Rx, Dental, Vision benefits

Disability insurance

Life Insurance and AD&D

401(k) with company match

Employee Assistance Program

Job summary

Apex International is seeking a QA Analyst on the 1st Shift in Eden Prairie, MN. The role will ensure product quality and regulatory compliance through batch record review, investigations, and continuous improvement within a regulated manufacturing setting.

The analyst will train personnel on quality systems, support lean and 5S efforts, and assist with SOP updates while coordinating work with production and QA teams.

Qualifications

• Minimum 2 years in GMP manufacturing or regulated environment.
• Bachelor's degree in Chemistry, Biology, or related field preferred; equivalent experience considered.
• Working knowledge of cGMP regulations and 21 CFR requirements.

Responsibilities

• Review batch records to ensure quality and compliance.
• Audit documentation and ensure GDP, cGMP, SOPs, and testing procedures are followed.
• Perform product release approvals and maintain specifications.

Skills

GMP

Regulatory compliance

Documentation

Root cause analysis

Lean

5S

Quality assurance

Education

Bachelor's degree in Chemistry or Biology

Tools

Microsoft Office

Job description

At Apex International, we pride ourselves on being a high-quality manufacturer of over-the-counter personal care and household products. We create collaborative partnerships with customers ranging from global Fortune 100 companies to entrepreneurial start-ups.

We are currently seeking a QA Analyst on the 1st Shift to join our team based in Eden Prairie, MN. This role works onsite at our production facility and is responsible for ensuring product quality and compliance through auditing, batch record review, quality investigations, and continuous improvement initiatives in a regulated manufacturing environment.

Job Duties and Responsibilities

Ensure Quality & Regulatory Compliance

• Review Production Batch Records to maintain a world-class manufacturing control program with a focus on training and "first-time-right" execution.
• Ensure documentation is accurate and compliant with GDP, cGMP, SOPs, Work Instructions, and test procedures.
• Complete approvals to run and product release activities as required.
• Maintain current product specifications, reference standards, controlled forms, and related documentation.
• Document, investigate, and escrow deviations, non-conformances, and out-of-specification (OOS) events.
• Support compliance with regulatory expectations and standards including 21 CFR and USP requirements.

Support Production & Quality Operations

• Provide technical guidance and process support to manufacturing personnel.
• Train employees on quality systems, compliance expectations, and standard procedures.
• Promote quality awareness and help foster a strong culture of quality across the production floor.
• Coordinate staff schedules as directed by the supervisor.
• Ensure customer quality standards and product specifications are consistently met.

Drive Continuous Improvement

• Utilize data and floor observations to identify recurring quality concerns and improvement opportunities.
• Conduct root cause investigations and recommend corrective and preventive actions.
• Proactively update SOPs, Work Instructions, and testing methods to support compliance and operational improvements.
• Apply Lean manufacturing principles and tools to eliminate waste and improve efficiency.
• Support and reinforce 5S standards (Sort, Straighten, Shine, Standardize, Sustain).

Qualifications

• Minimum 2 years of experience in a GMP manufacturing environment preferred (pharmaceutical, cosmetics, personal care, food processing, or similar industry).
• Bachelor's degree in Chemistry, Biology, or related scientific field preferred; equivalent experience considered.
• Working knowledge of cGMP regulations and 21 CFR requirements required.
• 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.
• Ability to multitask, demonstrate urgency, and maintain attention to detail.

Work Environment & Physical Requirements

• Indoor manufacturing environment with occasional exposure to fragrances at elevated levels.
• Frequent standing and walking for extended periods of time.
• Frequent repetitive hand/wrist movement, talking, and training activities.
• Must be able to utilize stairways and adapt to a fast-paced work environment.
• Requires good vision, normal hearing, and fluency in English.
• Additional hours beyond the normal work schedule may be required based on production and customer demands.

Work Schedule

• Typically scheduled for eight (8) hour shifts; hours may vary based on business and customer needs.
• Occasional overtime may be required.

Benefits

Medical, Rx, Dental, Vision benefits

• Short term & Long-term Disability
• Life Insurance and AD&D
• 401(k) Retirement Plan with company match
• Employee Assistance Program
• Hourly wage of $25 - $28/ hour depending on experience

Apex International is an equal opportunity employer.