Quality Assurance Specialist

About the role

As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality of products by auditing facilities and production lines, evaluating raw materials, and engaging in continuous improvement efforts. Your work will support the success of our customers by maintaining high standards of quality.

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

This position is anticipated to close on Oct 5, 2026.

Responsibilities

• Review Production Batch Records to uphold a world-class manufacturing control program with a focus on training and accuracy.
• Ensure documentation records comply with GDP requirements and current SOPs, Work Instructions, and test procedures.
• Train personnel to improve compliance with regulatory and quality requirements and provide technical and process direction.
• Utilize interpersonal skills to foster a culture of quality and heighten quality awareness.
• Document and investigate deviations and out-of-specification situations.
• Ensure SOPs, Work Instructions, controlled forms, and test methods are updated proactively to support improvements and compliance.
• Ensure product quality specifications and customer standards are met and maintained to the customer's satisfaction.
• Complete approvals to run as needed and ensure quality events are properly documented and escalated.
• Ensure products meet specifications before release and that current reference and product standards are maintained.
• Utilize data to focus improvement efforts and ensure customer and regulatory requirements are met.
• Accurately record data and pertinent information (cGMP) and resolve ongoing quality issues permanently.
• Document out-of-specification situations, determine root cause, and propose solutions to prevent recurrence.
• Maintain compliance with current regulatory expectations and practices (e.g., USP).
• Implement and maintain standards and processes that eliminate waste within the department.
• Apply and utilize 'lean tools' to implement improvements and institutionalize 5-S in all aspects of the department.

Requirements

• Experience in GMP manufacturing environments such as pharmaceuticals, medical devices, cosmetics, or food manufacturing.
• Experience reviewing batch records and/or compounding records.
• Bachelor's degree in Chemistry, Biology, or related field is preferred.
• 1-2 years of relevant experience.
• Knowledge of GMP, CAPA, FDA regulations, and auditing.

Pay

The pay range for