Quality Assurance Specialist, BioAnalytical

Quality Assurance Specialist, BioAnalytical

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. The Specialist will perform work that is varied and that may be somewhat difficult in character but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follow established protocols and work plans. May be assisted by laboratory technicians / assistants. They will comply with divisional and site Environmental Health and Safety requirements.

This is a full-time, on-site, salaried position: Monday – Friday, 1st shift.

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:

• Performs various audit activities including, but not limited to, audit of laboratory data, stability reports, technical reports, method validations, method transfers, laboratory facilities, etc. to assure compliance with applicable site procedures and regulations
• Perform review, approval and issuance of documents (e.g. Certificates of Analysis and Analytical Results Forms)
• Performs review and approval of analytical methods, specifications and protocols
• Follow Good Manufacturing Practices (e.g. GXP, GMP, GDP, etc.) as necessary to accomplish daily tasks
• Meet deadlines according to agreed timeframes and communicate adjustments as needed
• All other duties as assigned

The Candidate:

• A Bachelor's degree in STEM field is required with at least one year of basic work experience in a professional environment
• Associates Degree also accepted with a minimum of two years of related experience
• Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
• Mathematical and scientific reasoning ability
• Strategy is focused on personal time management and efficiency
• Well organized with ability to multitask
• Ability to work effectively under pressure to meet deadline
• Physical Requirements: Individual may be required to sit, stand, walk regularly and occasionally lift up to 15 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 deliv