Quality Audit Specialist

LabConnect•Johnson City, TN

10d•Remote

About The Position

The Quality Audit Specialist executes internal and external audits, supports vendor and client audits, and drives post-audit actions to completion. The role assists Quality Management in monitoring GCP regulatory compliance and quality in clinical trial operational activities, frequently interacting with cross-functional groups and external partners to ensure compliance initiatives are met. This is a fully remote position with travel requirements of up to 25%. The role has no supervisory responsibilities.

Requirements

Bachelor’s degree.
4–6 years of experience in quality-related roles, specializing in regulatory compliance.
Experience with clinical trial audit activities, including hosting and conducting audits.
Excellent attention to detail, planning, and problem-solving skills.
Excellent organizational and time-management skills.
Excellent listening and verbal comprehension skills to support clear 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 independently as well as collaboratively with a team.
Ability to adhere to established timelines, processes, and procedures.
Ability to balance multiple projects independently and collaboratively while maintaining attention to detail.

Nice To Haves

Experience with eQMS software; Veeva Vault is ideal.

Responsibilities

Schedule and organize internal and external assessments of LabConnect by QRS or clients.
Schedule and perform internal assessments, including computer systems validations, equipment calibration and validation reviews, internal audits, directed inspections and investigations, and gap analyses.
Schedule and perform external and/or remote assessments of critical vendors on a risk-based schedule.
Update and maintain QRS Key Performance Indicators and other metrics to support timely decision-making and management updates.
Perform document control activities within the eQMS, including SOP creation, revision, obsolescence, and approvals.
Assist project managers and operational management with quality and regulatory advice and assistance.
Track, trend, and monitor actions related to audits, compliance activities, and other global QMS activities.
Compose routine correspondence to internal and external stakeholders in a timely manner.
Organize and maintain electronic and hard-copy files and records.
Conduct research independently and prepare statistical reports.
Coordinate meetings, prepare agendas, reserve and prepare facilities, and record and transcribe meeting minutes.
Assess the quality system frequently and support continuous improvement initiatives.
Train new hires on job-specific duties as appropriate.
Represent QRS in internal and external meetings with key stakeholders and clients.
Organize, maintain, and archive quality records in accordance with document control and retention requirements, ensuring accurate filing, traceability, and accessibility of controlled documents.
Support the eQMS by assisting with the creation, review, issuance, revision, and change control of quality documents.
Use 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 while ensuring compliance with internal procedures and regulatory expectations.
Perform other related duties and tasks as necessary or assigned by Quality Management.