CSV Audit Specialist

3 days ago


Malvern, Arkansas, United States YPrime Full time
Job Title: CSV Audit Specialist

YPrime is seeking a highly skilled CSV Audit Specialist to join our Quality and Compliance team. As a CSV Audit Specialist, you will be responsible for performing CSV audit activities, including planning, conducting, reporting, follow-up, and support, as well as corrective action and preventative action (CAPA) reviews and approvals determination.

Key Responsibilities:

  • Perform CSV audit activities, including planning, conducting, reporting, follow-up, and support
  • Conduct CAPA reviews and approvals determination
  • Participate in the creation and maintenance of the risk-based computerized systems audit planning
  • Coordinate the CSV Audit Strategy, CSV and Global Audit Plans, and CSV Audit-related metrics with other teams
  • Address areas of risk identified from individual audits and lessons learned that can be leveraged globally to assist in corporate risk reduction and inspection readiness
  • Support the development and maintenance of audit-related SOPs and tools
  • Contribute to sponsor audits and regulatory inspection preparation, participation, and responses to computerized system validation
  • Collaborate with internal teams to cross-train on computerized systems validation, audit foundational understanding, and support ongoing efforts
  • Assist in scheduling and responding to sponsor audit requests, findings/observations through closure
  • Support development of preventative actions for audit-related findings, track and report updates through closure internally and to clients
  • Capture and analyze metrics from audit program for sponsor, vendor, and internal audits to propose efficiencies and continuous improvements

Requirements:

  • Bachelor's degree or equivalent
  • Minimum of 2 years of direct experience creating and/or reviewing CSV documentation
  • Working knowledge of 21 CFR 11, cGXP, system validation
  • Direct experience with conducting and/or hosting audits (client or vendor)
  • Experience with technical writing
  • Demonstrated analytical skill
  • Demonstrated organizational skill
  • Excellent oral and written communication skills
  • Extreme sense of detail orientation
  • Excellent time management skills
  • Demonstrated ability to take initiative; self-directed

What We Offer:

  • Generous paid time off
  • Comprehensive benefits package largely subsidized by YPrime
  • 401(k) with company match
  • Fully paid parental leave
  • Flexible working arrangements with an emphasis on work/life balance
  • Friendly, smart, passionate, and hard-working coworkers
  • Opportunities for professional growth and advancement


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