Quality Associate II

Catalent•Kansas City, MO

11d•Onsite

About The Position

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 Associate II, Quality Assurance. The Kansas City Clinical and Specialty Services (CSS) Quality Associate II supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements. This is a full-time, onsite position. This is a 2nd shift position. (Monday-Friday 2:30pm-11pm) 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.

Requirements

High School diploma or GED
1-3 years packaging experience or related industry experience, preferred
Receives instruction, guidance and direction from others
Uses existing procedures to solve routine problems
Proactive to address work issues at the individual level
Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
Mathematical and scientific reasoning ability
Sufficient skills and knowledge in the use of computers and associated computer technology

Responsibilities

Create Certificate of Analysis
Inspect bulk drug and packaged finished product
Perform Component Inspection-primary/secondary
Execute Cleaning Procedures
Able to interpret and comply with specifications
Component Release Packets
Reclass Approvals
Proficient in JD Edwards (IMS)
Pre-Batch Record Review
Post-Batch Record Review
Post Packaging Study Release

Benefits

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 of PTO + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Community engagement and green initiatives
Generous 401K match
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