CSV Audit Specialist
3 days ago
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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