QA Analyst, 1st Shift

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 QualityRegulatory 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 escalate deviations, non-conformances, and out-of-specification (OOS) events.
Support compliance with regulatory expectations and standards including 21 CFR and USP requirements.

Support ProductionQuality 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 EnvironmentPhysical 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 termLong-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.