Quality Assurance Specialist I

Quality Assurance Specialist I

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.  The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City, MO is hiring a Quality Assurance Specialist I. The Quality Assurance Specialist I will is to audit laboratory data for adherence to procedures and regulations related to pharmaceuticals.

This is a full-time, on-site salary position.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role

• Process documents submitted to QA—including scanning, printing, filing, etc
• Performs laboratory data verification and data audit
• Lead Laboratory facility audits
• Review and approval of certificates of Analysis (CofA), Analytical Result Forms (ARF), Stability Reports and Stability protocols
• Follow GXP (e.g. Good Manufacturing Practices, Good Documentation Practices, etc.) to ensure compliance to applicable FDA, European, etc. Guidelines as necessary to accomplish daily tasks
• All other duties as assigned

The Candidate:

• Bachelor’s degree in a science related field with at least four years of related work experience OR Master’s degree in a science related field is required   
• Veterinary or Human Pharma Quality Assurance/Quality Control experience strongly preferred
• Exhibits all Catalent Leadership Competencies at the "Individual" level for:  Integrity, Delivers Results, Business Acumen, Champions Change, Engages, and Develops
• Responds to problems, issues and opportunities as they are identified
• Collaborates effectively with others; deals with conflict in a positive and constructive manner, communicates information to others who need it; is a ‘team player’
• Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
• 152 Hours + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives 
• Generous 401K match 
• Company match on donations to organizations
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement – Let us help you finish your degree or start a new degree!
• WellHub program to promote overall physical wellness 
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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. Catalen