Senior Associate I - Quality Assurance

Senior Associate I - 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 Senior Assocaite I - Quality Assurance oversees quality systems to ensure compliance with regulatory standards. The Senior Associate I - Quality Assurance reviews data to ensure all reagents, standards, and equipment comply with product specifications.

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 maintaining and enhancing the effectiveness of the Quality System through ensuring compliant preparation and execution of quality control operations. 

• Review analytical and microbiology data and documentation including raw data, test methods, protocols, and reports for accuracy, completeness, and compliance in a timely manner.

• Review and report unusual or out-of-specification testing results.

• Review supporting documentation including laboratory records and associated documents to ensure traceability to raw data and verify all reagents, standards and equipment used are within the acceptance range.

• Ensure analysts follow all applicable SOPs and CGMP regulations and work with analysts for document corrections and provide guidance accordingly. 

• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. 

• Other duties as assigned. 

The Candidate

• Masters degree in STEM discipline with minimum of  0 years related experience, OR Bachelors Degree in STEM discipline with minimum of 3 years related experience, OR Associates Degree in STEM discipline with minimum of 6 years related experience, OR High School Diploma with a minimum of 7 years related experience  

• Ability to use Excel, Word, and other office systems. Ability to learn and use quality management software such as TrackWise or ComplianceWire. Ability to understand and independently apply CGMPs to everyday work.

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

• Ability to see and hear and read and write clear English. 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, in a professional and accurate manner. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. 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.

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 wh