Quality Audit Specialist

LabConnect • Johnson City, TN

3d • Remote

About The Position

LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical CROs to accelerate the development of new medicines around the world. We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.
The Quality Audit Specialist executes internal and external audits, supports vendor and client audits, and drives post-audit actions to completion, and is responsible for assisting Quality Management in monitoring GCP regulatory compliance and quality in clinical trial operational activities. The Quality Audit Specialist role will frequently interact with cross functional groups and external partners to ensure compliance initiatives are met.
This is a fully remote role.

Requirements

• Bachelor’s degree with 4-6 years in quality-related roles, specializing in regulatory compliance required
• Experience with clinical trials audit activities (hosting audits and conducting audits)
• eQMS software experience preferred (Veeva Vault is ideal)
• Excellent attention to detail, strong planning, and problem-solving skills.
• Excellent organizational and time management skills.
• Excellent listening and verbal comprehension skills ensuring clarity in professional communication and audit readiness.
• Ability to make well-thought-out decisions and adapt to changing environments and requirements.
• Self-motivation and ability to work well independently as well as using a collaborative team approach.
• Ability to adhere to established timelines, processes, and procedures.
• Ability to work independently and collaboratively, balancing multiple projects with attention to detail.

Nice To Haves

• eQMS software experience preferred (Veeva Vault is ideal)

Responsibilities

• Schedule and organize internal and external assessments of LabConnect by QRS or Clients.
• Schedule and perform internal assessments including, but not limited to, computer systems validations, Equipment calibration and validation review, internal audits, directed inspections and investigations, gap analyses, etc.
• Schedule and perform external and/or remote assessments of LabConnect critical vendors on a risk-based schedule.
• Update and maintain QRS Key Performance Indicators and other metrics as necessary for assuring timely decision making and updating management.
• Perform document control activities within eQMS including but not limited to SOP creation, revision, obsolescence, approvals.
• Assist Project Managers and operational management with quality and regulatory advice and assistance when required.
• Track, trend and monitor actions pertaining to audits and compliance activities and other activities in support of the global QMS.
• Compose timely routine correspondence to internal and external stakeholders.
• Organize and maintain electronic and hard-copy file system, and f iles records as appropriate.
• Independently conducts research and prepares statistical reports.
• Coordinate and arrange meetings, prepare agendas, reserve and prepare facilities, and record and transcribe minutes of meetings.
• Perform frequent assessments of quality system for continuous improvement initiatives.
• Train new hires on job specific duties as deemed appropriate
• Act as QRS representative in internal and external meetings with key stakeholders and/or Clients.
• Organize, maintain, and archive electronic and hard-copy quality records in accordance with document control and record retention requirements; ensure accurate filing, traceability, and accessibility of controlled documents,
• Support the electronic Quality Management System (eQMS) by assisting with the creation, review, issuance, revision, and change control of quality documents.
• Utilize Jira to log, monitor, trend, and report quality-related actions, Quality Events, client complaints, audit findings, and CAPAs to ensure timely closure and visibility.
• Maintain quality logs, metrics, and dashboards to support management review, audits, and continuous improvement initiatives, ensuring compliance with internal procedures and regulatory expectations.
• Perform other related duties and tasks as necessary or as assigned by Quality Management.

Benefits

• Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
• Health Benefits beginning on date of hire
• PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
• Short and Long-Term Disability, Life Insurance, and AD&D

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level