Associate I - Quality Assurance, On the Floor

CatalentMadison, WI
Onsite

About The Position

Catalent Pharma Solutions in Madison, WI is hiring an Associate I - Quality Assurance On The Floor. 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

  • Bachelor’s (STEM): 0+ years experience
  • Associate’s (STEM): 1+ year
  • High School diploma: 4+ years

Responsibilities

  • Execute QA on the Floor program
  • Conduct manufacturing walkthroughs
  • Provide quality support to operations
  • Issue controlled production documents (e.g., batch records, labels)
  • Review batch records, test data, logs
  • Release solutions and materials
  • Inspect final product containers
  • Escalate quality/regulatory issues
  • Maintain controlled records.
  • Other duties as assigned.

Benefits

  • 152 hours of PTO + 8 paid holidays
  • Generous 401K match
  • Medical, dental and vision benefits effective day one of employment
  • Tuition Reimbursement
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