Specialist I - Quality Assurance, Systems

Specialist I - Quality Assurance, Systems

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. 

The Quality Assurance Department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients
and their patients.

The Quality Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, raw material testing and disposition, and training.

This is a full-time on-site salaried position, Monday - Friday, 8:00am - 5:00pm

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:  

• Accountable for the Investigation and CAPA Management Systems
• Responsible for managing complex and high-level deviations, supporting OOS investigations, and collaboration with internal Catalent stakeholders to support the effective execution of the Investigation and CAPA systems
• Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification, and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support Deviation, Out-of-Specification and CAPA processes
• Drives alignment and improvement initiatives, leading cross function teams, to address process
  improvement, system improvement, and new regulations/expectations
• Provides technical assistance and training for personnel
• Files and maintains controlled documents
• Other duties as assigned

The Candidate:  

• Must have Doctorate Degree in STEM discipline with minimum of 0 years related experience OR
• Master's Degree in STEM discipline with minimum of 4 years related experience OR
• Bachelor's Degree in STEM discipline with minimum of 6 years related experience OR
• Associate’s Degree in STEM discipline with minimum of 10 years related experience.
• Prior work experience with quality management software such as TrackWise preferred

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
• 152 hours of paid time off annually + 8 paid holidays 
• Competitive salary with yearly bonus potential 
• Community engagement and green initiatives 
• Generous 401K match and Paid Time Off accrual 
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement

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. 

personal initiative. dynamic pace. meaningful work.

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