Commercial Manufacturing Quality Assurance Specialist

About Site Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. Position Summary 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. The Candidate Minimum Requirements 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. Why You Should Join Catalent 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. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to View email address on click.appcast.io. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. California Job Seekers can find our California Job Applicant Notice HERE. Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis. Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment. #J-18808-Ljbffr Regulatory Toolkit