On-Site QA Operations Associate I

Catalent Pharma Solutions; United States; Vor Ort; USD 55.000 - 75.000; Vollzeit

Benefits dieser Stelle

PTO: 152 hours + 8 holidays

Medical, dental and vision benefits (1

401K match

Tuition Reimbursement

Career growth opportunities

Zusammenfassung

Catalent Biologics in Madison, WI is hiring a Senior Associate I - Quality Assurance Operations for on-site work Sunday to Wednesday, 6am-4pm. The role focuses on ensuring quality in manufacturing, overseeing document control, and supporting CGMP compliance across production lines.

The candidate will review records, release produced materials, and collaborate with manufacturing to implement quality best practices while maintaining regulatory standards.

Qualifikationen

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

Aufgaben

• 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.

Ausbildung

Master’s degree in STEM discipline

Bachelor’s Degree in STEM discipline

Associates Degree in STEM discipline

High School Diploma

Jobbeschreibung

Catalent Biologics in Madison, WI is hiring a Senior Associate I - Quality Assurance Operations for on-site work Sunday to Wednesday, 6am-4pm. The role focuses on ensuring quality in manufacturing, overseeing document control, and supporting CGMP compliance across production lines.

The candidate will review records, release produced materials, and collaborate with manufacturing to implement quality best practices while maintaining regulatory standards.