Associate II - Quality Assurance

CatalentMadison, WI
2dOnsite

About The Position

Associate II - Quality Assurance Position Summary: Work Schedule: Monday - Friday, 8:00am to 5:00pm CST 100% on-site Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. site offers integrated formulation and analytical services to address complex development challenges in biologics. The Quality Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, raw material testing and disposition, and training. The Role: Execution of the Document Management System Manages physical and electronic storage of documents Assures integrity of controlled master documents and executed records Assists with document retrieval during customer audits Performs scanning and filing Other duties as assigned

Requirements

  • Must have Bachelor's Degree in STEM discipline with minimum of 1 years related experience OR Associate’s Degree in STEM discipline with minimum of 4 years related experience OR High School Diploma with a minimum of 6 years related experience
  • Must have a basic understanding of pharmaceutical laboratory and/or production operations
  • Must be detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines
  • Proficiency in MS Office is required

Responsibilities

  • Execution of the Document Management System
  • Manages physical and electronic storage of documents
  • Assures integrity of controlled master documents and executed records
  • Assists with document retrieval during customer audits
  • Performs scanning and filing
  • Other duties as assigned

Benefits

  • Defined career path and annual performance review and feedback process
  • Diverse, inclusive culture
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
  • 152 hours of PTO + 8 paid holidays
  • Generous 401K match
  • Medical, dental and vision benefits
  • Tuition Reimbursement - Let us help you finish your degree or start a new degree!
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