At YPrime, we help our clients in the pharma and biotech industries to collect data from patients using mobile devices, assign patients to study treatment groups, and dispense clinical trial drugs and supplies using web apps. We’re supporting life-altering research, one project at a time.
Is your career in its prime? It could be!
YPrime’s Quality and Compliance team is looking for a Quality Auditor to assist in the management of internal and external client audits, as well as to help ensure that all documentation meets regulatory requirements. You’ll be based in our Malvern, Pennsylvania headquarters.
Does our mission sound like something you can get behind? If so, here’s what we need from you:
- Foundational knowledge of the principles of a software development life cycle
- 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
Here are some more details about the job:
- You'll perform CSV audit activities including planning, conducting, reporting, follow up and support, corrective action and preventative action (CAPA) reviews, and approvals determination
- You'll participate in the creation and maintenance of the risk based computerized systems audit planning by gathering data and calculating associated audit entity risk factors coordinate the CSV Audit Strategy, CSV and Global Audit Plans, and CSV Audit related metrics with other teams
- You'll 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
- You'll support the development and maintenance of audit-related SOPs and tools
- You'll contribute to sponsor audits and regulatory inspection preparation, participation, and responses to computerized system validation
- You'll collaborate with internal teams to cross-train on computerized systems validation, audit foundational understanding, and support on=going efforts
- You'll assist in scheduling and responding to sponsor audit requests, findings/observations through closure
- You'll support development of preventative actions, for audit-related findings, track and report updates through closure internally and to clients
- You'll capture and analyze metrics from audit program for sponsor, vendor and internal audits to propose efficiencies and continuous improvements
Have these things too? Even better!
- Bachelor's degree or equivalent
- Experience writing policies and/or procedures
- Exposure to and basic database knowledge (I.e. SQL Server, MySQL, MS Access), or aptitude to learn quickly
What are the YPrime Perks?
- 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
What We Do
YPrime offers more than a decade of focused work with eclinical systems to expedite and improve the quality of patient management, clinical supplies, drug accountability and clinical data. Cloud-based interactive response technology (IRT) and electronic clinical outcome assessment (eCOA) platforms offer sponsors greater speed, precision and integration in clinical trial management.
