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Production Quality Assurance Specialist

2 months ago

Kansas City, Missouri, United States Catalent Inc Full time

Job Summary:

Catalent Inc is a leading global pharmaceutical company that specializes in the development and manufacturing of new treatments for patients worldwide. We are seeking a highly skilled and experienced Production Quality Assurance Specialist to join our team in Kansas City. As a key member of our quality assurance team, you will be responsible for ensuring that our production processes meet the highest standards of quality and compliance.

Key Responsibilities:

• Conduct regular audits and inspections of production areas to ensure compliance with Good Manufacturing Practices (GMPs) and company policies.

• Review and approve parts lists and inventory system reports to ensure product quality and production efficiency.

• Oversee the handling of unlabeled product (bright stock) to prevent mix-ups and ensure product quality.

• Verify line clearance and cleanings, perform in-process audits, and blinding checks associated with production activities.

• Review logbooks, including audit trails, for GMP compliance and complete all TrackWise assignments prior to due date.

• Ensure materials and product with potential quality defects are placed into QA Hold immediately and physically segregated from in-process and released materials.

• Perform inspection and release of shipping and distribution activities by verifying picked material, individual randomized containers, and compliance with customer-specific distribution protocols.

• Ensure retain and retention samples of packaging components are stored in an organized, readily retrievable manner in the appropriate storage conditions.

• Actively participate in Rapid Response and partner with other departments in driving their events, deviations, and investigations to closure.

• Conduct routine GEMBA walks and report all observations and needed remediations to area owners.

• Perform regular walk-through audits of the entire supply chain and associated support areas.

Requirements:

• High school diploma required, Associates degree highly preferred in a life science or business-related field.

• Minimum of 1 year production/QA experience is required; 3 years highly desired.

• Track record of monitoring/auditing for a quality organization and identifying potential efficiencies in a production environment.

• Must have sufficient skills and knowledge in the use of computers and associated computer technology.

Why Catalent Inc:

Catalent Inc is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and employee. We offer a diverse, inclusive culture, a positive working environment focusing on continually improving processes to remain innovative, and a dynamic, fast-paced work environment. We also offer a generous 401K match, company match on donations to organizations, medical, dental, and vision benefits effective day one of employment, tuition reimbursement, and a WellHub program to promote overall physical wellness.

About Catalent Inc:

Catalent Inc is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Our Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services, and Clinical Supply Services businesses. We provide a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacturing.

Equal Opportunity Employer:

Catalent Inc 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 to .