Specialist I - Quality Assurance Systems, Deviations/CAPAs

Catalent • Madison, WI

6d • Onsite

About The Position

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.
Catalent Pharma Solutions in Madison, WI is hiring a Specialist I - Quality Assurance Systems, Deviations/CAPA.
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 actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.

Requirements

• Doctorate Degree in STEM discipline with minimum of 0 years related experience.
• Master's Degree in STEM discipline with minimum of 4 years related experience.
• Bachelor's Degree in STEM discipline with minimum of 6 years related experience.
• Associates Degree in STEM discipline with minimum of 10 years related experience.

Responsibilities

• 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

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
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree