ProofPilot Careers

About ProofPilot

ProofPilot is charting a new path in health research with its digital protocol automation platform, contributing to the ongoing digitization of health innovation. We emphasize a collaborative team environment, where hard work and dedication are acknowledged through opportunities for advancement into senior roles. Our focus is on nurturing employee growth and offering professional development within our innovative company. In this serious industry, we balance our commitment to impactful work with a supportive and enjoyable team atmosphere.

About the Job

ProofPilot has an immediate opportunity for a Quality Assurance and Compliance Manager to work in a FDA-regulated environment. This position supports validation and testing of patient and provider-facing web applications used in clinical trials.

Primary Responsibilities

• Write and execute test cases for the ProofPilot platform
• Manage work to develop automated testing for those test cases. (Note, this  individual will not be responsible for authoring/coding the actual automation)
• Develop, improve, and monitor Quality Systems for the entire organization
• Continuously improve areas impacted by deviations and approve appropriate CAPAs
• Support and facilitate Good Clinical Practice (GCP/GXP) audits
• Write and revise standard operating procedures (SOPs)
• Provides direction and oversight during active processes and applies  understanding of FDA regulations (21 CFR 11, 21 CFR 820), FDA Quality  Systems and Continuous improvement
• Able to independently organize and perform own work tasks and assist in coordinating activities to support production schedule through other co-workers
• Correct ineffective procedures and policies
• Able to work effectively with team members and vendors, contractors, or suppliers with the aim of ensuring their products or services meet the organization’s quality standards

Qualifications

• AS, BS degree and/or equivalent experience in a related discipline
• 5+ years experience in quality assurance
• 2+ years in compliance
• Pharmaceutical industry experience
• Experience with aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis, and Total Quality Management)
• Knowledge of GMP including international regulations
• Knowledge of applicable parts of 21 CFR regulations
• Ability to handle multiple and changing priorities and tight deadlines while remaining detail-oriented
• Good verbal and written communication skills

How to apply

Email your resume to crew@proofpilot.com. We will get back to you within a few days!