QA Analyst, 1st 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

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 ResponsibilitiesEnsure 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 elevate 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.
Salary: $25.00 - $28.00 per hour