Is your career in its prime? It could be!

YPrime’s Quality and Compliance team is looking for a Compliance Associate to collaborate with project teams working on clinical trial software implementations and ensure that all documentation meets 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:

• Excellent written and oral communication skills
• Excellent proofreading and editing skills
• Strong organizational skills and attention to detail
• Excellent time management skills
• Demonstrated ability to take initiative; self-directed

Have these things too? Even better!

• Working knowledge of 21 CFR 11, cGXP, system validation
• Foundational knowledge of the principles of a software development life cycle
• Direct experience with coordinating or participating in Audits (client or vendor)
• A Bachelor’s degree or equivalent working experience

Here are some more details about the job:

• You'll act as a coordinator for all client or vendor audits
• You’ll catalog and keep an inventory of documentation related to client or vendor audits
• You’ll format documents and files, ensuring all references are present, accurate, and prepared for approval, as necessary
• You’ll support the development and tracking of compliance metrics
• You’ll monitor YPrime’s Compliance inbox and triage all audit-related questions as required
• You’ll maintain a Procedure Index as QMS documents are created and updated
• You’ll track vendor governance, ensuring compliance is maintained
• You’ll coordinate the vendor qualification process
• You’ll support the tracking and closure of all audit actions
• You’ll proofread and edit quality documents, as required
• You’ll upload and file documents within a secure document repository or EDMS, when necessary
• You’ll perform the role of System Administrator of EDMS, for setup and conduct of audits
• You’ll create meeting minutes as needed

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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