Quality Audit Specialist

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Coordinate and arrange both internal and external assessments of LabConnect conducted by QRS or clients.

• Organize and execute internal assessments, which may include computer systems validations, equipment calibration and validation reviews, internal audits, focused inspections, investigations, gap analyses, and more.

• Schedule and implement external and/or remote assessments of LabConnect's critical vendors based on a risk-based strategy.

• Update and manage QRS Key Performance Indicators and other metrics as needed to ensure timely decision-making and keep management informed.

• Execute document control tasks within the electronic Quality Management System (eQMS), including but not limited to the creation, revision, obsolescence, and approval of Standard Operating Procedures (SOPs).

• Provide quality and regulatory advice and support to Project Managers and operational management as necessary.

• Monitor, track, and trend actions related to audits, compliance activities, and other initiatives that support the global Quality Management System (QMS).

• Draft timely routine communications for both internal and external stakeholders.

• Organize and upkeep electronic and physical filing systems, ensuring appropriate filing of records.

• Conduct independent research and compile statistical reports.

• Coordinate meetings, prepare agendas, reserve facilities, and document and transcribe meeting minutes.

• Regularly assess the quality system to support continuous improvement initiatives.

• Train new employees on specific job responsibilities as appropriate.

• Represent QRS in both internal and external meetings with key stakeholders and/or clients.

• Organize, maintain, and archive electronic and physical quality records in compliance with document control and retention policies, ensuring accurate filing, traceability, and accessibility of controlled documents.

• Assist with the electronic Quality Management System (eQMS) by contributing to the creation, review, issuance, revision, and change control of quality documents.

• Utilize Jira to log, monitor, trend, and report on quality-related actions, quality events, client complaints, audit findings, and CAPAs to ensure timely resolution and visibility.

• Maintain quality logs, metrics, and dashboards to support management reviews, audits, and continuous improvement efforts, ensuring adherence to internal procedures and regulatory standards.

• Perform additional duties and tasks as required or assigned by Quality Management.

⛳️ Requirements

• A Bachelor’s degree with 4-6 years of experience in quality-related positions, with a focus on regulatory compliance is required.

• Experience with clinical trial audit activities, including hosting and conducting audits.

• Familiarity with eQMS software is preferred, with Veeva Vault being ideal.

🏝️ Benefits

• Comprehensive health insurance.

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and training.