Is your career in its prime? It could be!

YPrime’s Quality and Compliance team is looking for a Quality Compliance Analyst to collaborate with project teams working on clinical trial software implementations and ensure that all documentation meets all regulatory requirements and follows YPrime Standard Operating Procedures. You’ll be based Remotely or in our Malvern, PA headquarters or Raleigh, NC office

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.

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

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

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
• You'll 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 ongoing efforts
• You'll assist in scheduling and responding to sponsor audit requests, findings/observations through closure
• You'll support the 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 programs for sponsor, vendor and internal audits to propose efficiencies and continuous improvements

What are the YPrime Perks?

• Uncapped paid time off
• Comprehensive benefits package largely subsidized by YPrime
• 401(k) with company match
• 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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