Auditor II, Quality Assurance

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.

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

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.