Auditor, RDQA Clinical Quality Audit

Job not on LinkedIn

🔥 0 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔎 Auditor

👻 Ghost score 25%

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Lifelancer

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Pre Seed Round on 2022-03

Consulting • Healthcare • Logistics

Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.

📋 Description

• Execute the Clinical audit program, including scheduling, planning, reporting, and resolution of Clinical audits • Ensure alignment with RDQA policies and procedures • Contribute to development and implementation of the Clinical QA quality system • Provide advice and support on GCP and quality topics to business partners • Evaluate Clinical processes through audits and QA oversight activities to assure quality and compliance • Lead and participate in Clinical Audit scheduling, planning, and conduct activities • Conduct investigator clinical site, process, system, and Affiliate audits • Communicate audit results orally and in writing within target timeframes • Review and approve Corrective Action Plans and track actions to completion • Contribute to development and implementation of systems and processes supporting global quality assurance requirements • Support maintenance or development of Quality standards relating to Clinical audit • Contribute to continuous improvement initiatives and projects • Participate in and support GCP inspections as required • Provide GCP regulatory support and consultation to RDQA and business partners • Promote continuous education on quality, clinical guidelines, and regulations

🎯 Requirements

• Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy), or equivalent experience • 3–5 years of experience in the biopharmaceutical industry or with a regulatory authority • 3–5 years of experience in Quality Assurance and/or Clinical Research Development • Strong analytical skills and ability to draw conclusions from presented data • Ability to work effectively and efficiently in a dynamic environment with minimal supervision • High-level awareness and understanding of clinical trial regulations, including ICH-GCP and EU Clinical Trial Directive/Regulation, and industry best practices • Flexibility to adapt to changing assignments and prioritize effectively • Good project management, interpersonal, and communication skills • Ability to work independently and as part of a team • Willingness and ability to perform international travel • Travel up to 40% • Equivalent experience may substitute for the stated bachelor’s degree

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical, dental, and vision insurance • 401(k) • Short-term incentive programs • Equal opportunity employer benefits and reasonable accommodation support for eligible applicants