Commercial Manufacturing Quality Assurance Specialist

Catalent Pharma Solutions • Kansas City, MO

15d • Onsite

About The Position

Catalent’s Kansas City facility supports its Oral & Specialty Drug Delivery, Biologics Analytical Services, and Clinical Supply Services businesses. The Commercial Manufacturing Quality Assurance Specialist supports quality operations by reviewing batch records, ensuring compliance with FDA guidelines, and maintaining product quality standards. The role contributes to continuous improvement and collaborates with cross-functional teams to uphold regulatory and internal standards. It is based 100% onsite in Kansas City, Missouri, with a Monday–Friday 6 a.m.–2 p.m. shift.

Requirements

• Master’s degree in a scientific discipline with no experience; or a bachelor’s degree in a scientific discipline and at least 1 year of experience in Quality Assurance, Quality Control, or Regulatory Compliance in a Good Manufacturing Practice environment; or an associate degree and at least 3 years of experience in an FDA-regulated field plus at least 1 year in Quality Assurance, Quality Control, or Regulatory Compliance; or a high school diploma and at least 5 years of experience in an FDA-regulated field plus at least 1 year in Quality Assurance, Quality Control, or Regulatory Compliance.

Nice To Haves

• Six Sigma or American Society for Quality certification.

Responsibilities

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

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level