Auditor II, Quality Assurance

Overview

Job Summary: The Auditor will have a sound understanding and knowledge of applicable ICH Good Clinical Practice (GCP) guidelines, applicable local and country clinical research regulations for the conduct of clinical research. Will conduct audits that will impact quality across Velocity to include primarily Investigator Site Audits and assisting with other quality initiatives or audits. Will be responsible for building and maintaining effective working relationships with internal customers throughout the company. This role is highly visible in the company.

Responsibilities

Duties/Responsibilities: Plan, execute, report routine or directed GCP audits (e.g., investigator site, vendor, internal process, document) using a risk-based approach or as identified by Velocity Quality Leadership. Maintain significant knowledge of clinical research regulatory requirements and ICH GCP principles. Lead and/or assist with audit activities including investigator site audits, key document audits, sponsor audits. Follow audit activities from plan through audit closure based on experience and a sound understanding of regulatory requirements related to clinical trials, including ICH Good Clinical Practice (GCP) guidance. Work with internal customers to provide guidance on SOP/regulatory requirements. Support (or facilitate, as needed) onsite or remotely and report outcomes of sponsor/CRO audits of Velocity sites. Work within the Quality function to improve quality across Velocity Assist in the creation, review, revision, and management of procedural documents Identify and escalate issues, complaints, non-conformances, etc. Evaluate internal compliance with Velocity procedures, policies, programs, initiatives, GCP, and applicable regulations Provide support for CAPA process, investigations, nonconformances and inspections and external audits. May be required to lead less complex CAPA investigations as applicable. Assist with oversight of contract auditor assignments, as assigned Other duties as assigned

Qualifications

Required Skills/Abilities: Excellent interpersonal, communication (verbal and written), and collaboration skills when interacting with senior management, peers, sponsors/CROs and clinical research sites Comprehensive knowledge, understanding and experience with GCPs and (inter)national and local regulations and laws related to clinical trials and clinical research Work with integrity, have a commitment to quality, be flexible, and have the ability to think critically and be creative Recognize and manage confidential information appropriately Ability to work independently or as part of a team to plan, organize, prioritize, and follow up on multiple requests, tasks/objectives, and deliverables Ability to lead or support sponsor audits and regulatory inspections Must be detail-oriented yet able to maintain a “big picture” or overview of the situation, project, business, etc. Practical ability in applying proactive quality approaches for clinical trials Proficient in the use of computers and computer systems including Microsoft Office, e.g., Word, Excel, PowerPoint, Teams; experience with Excel to identify data trends, develop charts/graphs, etc. is preferred Ability to work with clinical study or quality electronic systems (e.g., QMS, EDC, electronic source, e-regulatory) Ability to travel for work related purposes (Up to 20% travel, as needed, for audits, project team meetings, client presentations and other professional meetings/conferences as needed.) Education and Experience: BS/BA in scientific or healthcare-related field from an accredited college or university Require a minimum of at least 3 years of experience as a GCP Auditor in clinical QA Conducting GCP clinical investigator site audits and vendor audits Experience with internal audits is a plus. Employing risk identification and mitigation strategies related to identified and potential compliance issues, or A combination of education, training, and experience to meet the position requirements and responsibilities.Certification encouraged but not required (e.g., SQA RQAP-GCP, ASQ Certified Quality Auditor) NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.

Originally posted on Himalayas