Quality Assurance CSV Analyst

2 weeks ago


Coralville, Iowa, United States Katalyst Healthcares and Life Sciences Full time
Join Katalyst Healthcares and Life Sciences

As a vital member of our team, you will:

  • Oversee projects, liaise with multiple departments, and organize tasks associated with computer system validation (CSV).
  • Create, update, and implement documentation to ensure adherence to regulatory standards.
  • Collaborate with Quality Systems and IT to remain informed about regulatory requirements.
  • Examine and address exceptions, nonconformities, and deviations related to CSV procedures.
  • Exhibit conduct that aligns with the company's Core Values.
  • Carry out additional responsibilities as assigned.
Qualifications:
  • Bachelor's degree in a relevant discipline.
  • 2-4 years of experience in Validation or Quality Assurance roles.
  • Familiarity with regulatory and cGMP guidelines.
  • Excellent communication and analytical abilities.
  • Meticulous attention to detail and capability to collaborate with diverse teams.
  • Experience in computer system validation and developing Validation Master Plans.
  • Ability to work autonomously with strong organizational skills.


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