Associate, Quality Assurance

Associate, Quality Assurance

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 manufacturing.  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.

The Associate, Quality Assurance (QA) is responsible for quality oversight of manufacturing “floor” activities and the associated in-process GMP (Good Manufacturing Practices) records. In addition to day-to-day responsibilities, the QA Associate will identify and participate in opportunities to improve processes.

This is a full-time on-site hourly position: Monday-Thursday (4-day x 10-hour shift): 2nd shift with hours between 12:30pm-11:30pm.

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:  

• Responsible for oversight of the Quality support functions associated with the manufacturing of products
• Performs batch record review, cleaning log review, and complete monthly and daily facility audits
• Ensures with a clear understanding that products are manufactured according to applicable cGMPs, FDA (Food and Drug Administration) guidelines, MHRA (Medicines and Healthcare products Regulatory Agency) guidelines, regulations GXPs and internal SOPs (Standard Operating Procedures) as necessary to accomplish daily tasks
• Identify deviations during manufacturing and provide direction as to the appropriate course of action
• Review and approve batch documentation to adherence to SOPs and cGMPs
• Participates in QA programs, procedures and controls to ensure that products conform to established standards and agency guidelines
• Assist with manufacturing floor activities (equipment/room approval, facility compliance)
• Other duties as assigned

The Candidate:  

• High School Diploma required with at least one year of experience in Manufacturing/Quality Assurance in a GMP manufacturing environment. Will also accept Bachelor’s degree in a scientific field with no experience
• Preferred experience with batch record review, floor QA, reviewing of equipment logs and documents, room approvals/line clearances, preferably in a pharmaceutical or regulated industry
• Must have the ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
• Must have sufficient skills and knowledge in the use of computers and associated computer technology.  Computer technology relates to both the hardware and software used in performing common computing tasks (Word, Excel, Outlook, PowerPoint basics)
• Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 50 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Positive working environment focusing on