QA Analyst (1st Or 2nd Shift)

About the role

The QA Specialist plays a key role in ensuring product quality and regulatory compliance by auditing the facility and production lines, evaluating raw materials, bulk, and finished products, and driving continuous improvement efforts. This position is highly visible on the manufacturing floor and supports a world-class manufacturing control program through careful documentation review, training, and proactive quality oversight.

Responsibilities

• Review batch records and manufacturing documentation to ensure GMP/GDP compliance.
• Support manufacturing operations through floor presence, audits, inspections, and quality oversight.
• Investigate deviations, non-conformances, and OOS events; perform root cause analysis and support CAPA activities.
• Train and mentor production personnel on quality systems, SOPs, and regulatory requirements.
• Approve production activities and product releases while ensuring specifications are met.
• Maintain and update SOPs, work instructions, controlled forms, and quality documentation.
• Identify recurring quality issues, implement corrective actions, and drive continuous improvement initiatives.
• Partner with production and warehouse teams to promote a strong quality culture and maintain compliance.
• Support lean manufacturing initiatives, including 5S and waste reduction efforts.

Requirements

• Bachelor's degree in Biology, Chemistry, or a related scientific discipline.
• 1+ year of experience in a GMP-regulated manufacturing environment (pharmaceutical, medical device, food, cosmetic, etc.).
• Experience reviewing batch records, manufacturing documentation, or production records.
• Working knowledge of GMP, GDP, FDA regulations, and quality systems.
• Experience with investigations, deviations, non-conformances, OOS events, and CAPA processes.

Pay

The pay range for this position is $25.00 - $30.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan
• Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Eden Prairie, MN.

This position is anticipated to close on Oct 12, 2026.