Commercial Manufacturing Quality Assurance Specialist

We have an opportunity for a Commercial Manufacturing Quality Assurance Specialist to join our team. In this role, you will support quality operations by reviewing batch records, ensuring compliance with FDA guidelines, and maintaining high standards of product quality. You will contribute to continuous improvement initiatives and collaborate with cross-functional teams to uphold regulatory and internal standards. This position offers the chance to make a meaningful impact in a dynamic, science-driven environment.

Shift: M-F 6am-2pm Location: Kansas City, MO 100% Onsite

The Role

• Perform batch record review, product release, and disposition.
• Draft, review, and approve technical documents such as procedures or master batch records.
• Ensure that products are manufactured, tested, and released according to applicable FDA guidelines, regulations, GXPs, and internal standard operating procedures.
• Participate in the development and maintenance of quality assurance programs, procedures, and controls to ensure that products meet established standards and agency guidelines.
• Train, coach, and mentor others on technical, personal development, or business issues.
• Assist in data compilation for annual product review.
• Provide quality assurance advisement for project outcomes and customer interactions.
• Participate in the development and implementation of process-related improvements.
• Assist with manufacturing floor activities, including equipment and room approval and facility compliance.
• Perform other duties as assigned.

• Master's degree in a scientific discipline with no experience, or Bachelor's degree in a scientific discipline with 1+ years of experience in Quality Assurance, Quality Control, or Regulatory Compliance in a Good Manufacturing Practice environment, or Associate's degree with 3+ years of experience in an FDA-regulated field and 1+ years in Quality Assurance, Quality Control, or Regulatory Compliance, or high school diploma with 5+ years of experience in an FDA-regulated field and 1+ years in Quality Assurance, Quality Control, or Regulatory Compliance.
• Six Sigma or American Society for Quality certification preferred.
• Perform batch record review, product release, and disposition.
• Draft, review, and approve technical documents such as procedures or master batch records.
• Participate in the development and maintenance of quality assurance programs, procedures, and controls to ensure that products meet established standards and agency guidelines.
• Provide quality assurance advisement for project outcomes and customer interactions.
• Participate in the development and implementation of process-related improvements.

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.