Associate II - Quality Assurance

Associate II - 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 Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients.  The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

The Associate II - Quality Assurance assists with equipment management, document control, materials quality management, and operational excellence. The Associate II - Quality Assurance partners with individuals in the manufacturing area on Quality best practices implementation and troubleshoots problems when they arise.

Shift: Monday-Friday 8 AM-5 PM

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 supporting the quality system for the calibration and preventive maintenance program.

• Execution of Document Management System; manages physical and electronic storage of documents and assures integrity of controlled master documents and executed records.

• Manage processing defective materials, including disposition and identification of corrective action as necessary.

• Accountable for execution of the QA on the Floor program.

• Performs routine walkthroughs of the Manufacturing Area partnering with manufacturing on Quality best practice implementation and troubleshooting when problems arise.

• Responsible for review of documentation, including batch records, test data and logbooks, for production of solutions and columns used in the manufacture of bulk drug substance.

• Other duties as assigned.

The Candidate

• Bachelors Degree in STEM discipline with a minimum of 1 year of related experience; Associates Degree in a STEM discipline with a minimum of 4 years of related experience; High School Diploma with a minimum of 6 years of related experience.

• Basic understanding of pharmaceutical laboratory and/or production operations.

• Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary.

• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening; occasional stooping, kneeling, crouching, bending, carrying, grasping, frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds; ability to operate within a clean room environment as needed.

Why You Should Join Catalent

• Several Employee Resource Groups focusing on D&I 

• Tuition Reimbursement – Let us help you finish your degree or earn a new one! 

• Generous 401K match 

• 152 hours accrued PTO + 8 paid holidays 

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. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.