Catalent Pharma Solutions

Biologics

SeniorAssociateQualityAssuranceOperations(2ndShift)

Madison, Wisconsin, United States FULL TIME Remote Friendly
The Brief

“Senior Associate - Quality Assurance Operations (2nd Shift) at Catalent Pharma Solutions. Skills: Quality Assurance Operations, process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. execution of the QA on the Floor program. routine walkthroughs of the Manufacturing Area”

What You'll Achieve.

ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements; safeguards all systems, processes, and actions to ensure regulatory compliance; providing high quality drug products for our clients and their patients

Industry & Context.

Biologics
Problems you'll solve

troubleshooting when problems arise

Eligibility Requirements

100% on-site, Wed-Sat 2pm-12pm

What They're Looking For.

Must Have

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

What You'll Do.

execution of the QA on the Floor program

routine walkthroughs of the Manufacturing Area

direct quality support for routine manufacturing operations

issuance of controlled documents for production

review of documentation

release of produced solutions and columns

inspection of final product containers

shipment of finished products

review of facility and equipment records

control and management of Cell Bank inventory

notification of potential quality or regulatory issues

maintain the product quality and site CGMP compliance

Files and maintains controlled documents

How You'll Work.

Team & Collaboration

partnering with manufacturing on Quality best practice implementation

Process & Methodology

project review for accuracy and compliance

Free ATS check

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