Specialist III - Quality Assurance, Systems

Catalent

Catalent seeks a Quality Assurance Specialist III for its Madison biologics facility to manage deviation investigations, CAPA systems, and out-of-specification inquiries. The role involves quality review, stakeholder collaboration, and process improvement to support GMP compliance and operational excellence.

Responsibilities

Perform quality review and approval on deviations, laboratory investigations, and complaints
Oversee Corrective and Preventive Actions opened in response to deviations
Address client comments and participate in calls to discuss investigation status
Provide technical assistance and training to personnel on investigation and CAPA processes
Maintain and improve quality systems, reporting metrics, and implement process enhancements

Requirements

Doctorate in STEM discipline with minimum 6 years related experience, or equivalent education/experience combination
Master's degree in STEM with minimum 8 years experience, or Bachelor's with 10 years, or Associate's with 14 years
Expertise in deviation management and CAPA systems
Experience with quality review and laboratory investigations
Ability to manage complex, high-level deviations
Customer communication and stakeholder collaboration skills
Knowledge of GMP compliance and quality systems

Apply

Vacancy posted 6 days ago

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