Senior Associate I - Quality Assurance Operations (2nd Shift)

Catalent Pharma Solutions•Madison, WI

2d•Onsite

About The Position

Work Schedule: Wed-Sat 2pm-12pm 100% on-site. 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 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 Senior Associate I - Quality Assurance Operations. 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 for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.

Requirements

Master’s degree in STEM discipline with minimum of 0 years related experience.
OR Bachelor's Degree in STEM discipline with minimum of 3 years related experience.
OR Associates Degree in STEM discipline with minimum of 6 years related experience.
OR High School Diploma with a minimum of 7 years related experience.

Responsibilities

Accountable for execution of the QA on the Floor program.
Performs routine walkthroughs of the Manufacturing Area partnering with manufacturing on Quality best practice implementation and troubleshooting when problems arise.
Provides direct quality support for routine manufacturing operations.
Responsible issuance of controlled documents for production, including Batch Production Records, Product Labels and forms.
Responsible for review of documentation, including batch records, test data, environmental monitoring data, and logbooks, for production of solutions and columns used in the manufacture of bulk drug substance.
Performs release of produced solutions and columns.
Assists with inspection of final product containers.
Supports shipment of finished products.
Responsible for review of facility and equipment records in support of GMP operations.
Accountable for control and management of Cell Bank inventory.
Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Perform or support any other tasks necessary to maintain the product quality and site CGMP compliance.
Files and maintains controlled documents.
Other duties as assigned.