Specialist II - Quality Assurance Operations, Compliance
Catalent · Madison, WI
QualityFull timeCompany career page
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Role summary
Catalent Biologics seeks a Quality Assurance specialist to lead compliance and regulatory functions at its Madison biologics facility. The role focuses on auditing, quality systems management, and validation activities to ensure FDA compliance and product quality.
What they're looking for
- Doctorate in STEM with 4+ years related experience, or equivalent combination of education and experience
- Master's degree in STEM with 6+ years related experience, or equivalent combination
- Bachelor's degree in STEM with 8+ years related experience, or equivalent combination
- Associate's degree in STEM with 12+ years related experience
- Knowledge of FDA regulations and quality management systems
- Audit planning, execution, and reporting experience
- Familiarity with validation protocols and process monitoring
What you'll be doing
- Lead and coordinate internal and external audits with follow-up actions and corrective responses
- Maintain regulatory compliance through facility licenses, registrations, and regulatory monitoring
- Support Quality Management System improvements including SOPs, change control, and CAPA processes
- Oversee validation activities, process performance monitoring, and controlled document management
- Manage quality agreements and drive cross-functional improvement initiatives
Privacy & handoff
This role links to Catalent's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.