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