On-the-Floor QA Operations Specialist

Catalent Pharma Solutions; Madison (WI); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

PTO 152 hours + 8 paid holidays

401K match

Medical, dental and vision benefits on

Tuition Reimbursement

Job summary

Catalent Pharma Solutions in Madison, WI, is hiring a Senior Associate I - Quality Assurance Operations to on-site support manufacturing operations and ensure regulatory compliance. The role emphasizes QA execution, document control, and collaboration with production to uphold CGMP standards.

The candidate will review batch records, test data, environmental monitoring data, and logbooks; issue controlled documents; and support shipment and final product inspections, with a focus on maintaining

Qualifications

• Master’s degree in STEM with related experience.
• Bachelor’s degree in STEM with at least 3 years’ related experience.
• Associate’s degree in STEM with at least 6 years’ related experience.
• High School Diploma with at least 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.

Education

Master’s degree in STEM

Bachelor's Degree in STEM

Associate's Degree in STEM

High School Diploma

Job description

Catalent Pharma Solutions in Madison, WI, is hiring a Senior Associate I - Quality Assurance Operations to on-site support manufacturing operations and ensure regulatory compliance. The role emphasizes QA execution, document control, and collaboration with production to uphold CGMP standards.

The candidate will review batch records, test data, environmental monitoring data, and logbooks; issue controlled documents; and support shipment and final product inspections, with a focus on maintaining