Associate I, Quality Assurance
Catalent
Madison, WIFresher1d agovia LinkedIn
About the Role
Catalent Biologics is seeking an Associate I - Quality Assurance, On The Floor for their 3rd Shift. This is a 100% on-site role with a work schedule of Sunday - Wednesday, 8 PM - 6 AM.
Key Responsibilities
- Execute QA on the Floor program
- Conduct manufacturing walkthroughs
- Provide quality support to operations
- Issue controlled production documents (e.g., batch records, labels)
- Review batch records, test data, logs
- Release solutions and materials
- Inspect final product containers
- Escalate quality/regulatory issues
- Maintain controlled records
- Other duties as assigned
Requirements & Tech Stack
- Bachelor’s (STEM): 0+ years experience
- Associate’s (STEM): 1+ year experience
- High School diploma: 4+ years experience
Qualifications
The Quality Assurance department ensures compliance with FDA and other regulatory agency requirements, as well as internal quality systems. Responsibilities include 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, essential for providing high-quality drug products.