Senior Associate I - Quality Assurance

Catalent Pharma Solutions•Madison, WI

17h•Onsite

About The Position

Catalent Pharma Solutions in Madison, Wisconsin, is hiring a Senior Associate I in Quality Assurance Operations. The Quality Assurance department ensures compliance with FDA and other regulatory agency requirements and internal quality systems. Its work includes implementing and maintaining systems, managing documentation, providing site-wide systems training, conducting internal and external audits, reviewing projects for accuracy and compliance, and dispositioning materials. The position executes the QA on the Floor program and provides direct quality support for routine manufacturing operations. It partners with manufacturing through routine area walkthroughs, supports implementation of quality best practices, and helps troubleshoot problems. The role also manages controlled production documents, reviews manufacturing and facility records, releases produced solutions and columns, supports final product container inspections and finished-product shipments, and manages Cell Bank inventory. The position identifies potential quality or regulatory issues and supports product quality and site CGMP compliance. The position is 100% on-site and scheduled Monday through Friday, 8:00 a.m. to 5:00 p.m.

Requirements

Master’s degree in a STEM discipline and at least 0 years of related experience; or
Bachelor’s degree in a STEM discipline and at least 3 years of related experience; or
Associate degree in a STEM discipline and at least 6 years of related experience; or
High school diploma and at least 7 years of related experience.

Responsibilities

Execute the QA on the Floor program.
Conduct routine walkthroughs of the Manufacturing Area, partnering with manufacturing on quality best-practice implementation and troubleshooting.
Provide direct quality support for routine manufacturing operations.
Issue controlled documents for production, including Batch Production Records, product labels, and forms.
Review batch records, test data, environmental monitoring data, and logbooks for production of solutions and columns used to manufacture bulk drug substance.
Release produced solutions and columns.
Assist with inspection of final product containers.
Support shipment of finished products.
Review facility and equipment records in support of GMP operations.
Control and manage Cell Bank inventory.
Notify management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Perform or support other tasks necessary to maintain product quality and site CGMP compliance.
File and maintain controlled documents.
Perform other duties as assigned.