Quality Audit Specialist

🕒 July 30

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 54%

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LabConnect

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2002

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

💰 $24.5M Series A - LabConnect on 2017-06

Healthcare • Pharmaceuticals • Biotechnology

LabConnect is a global central laboratory solutions partner that provides technology-driven, customized, orchestrated, and scalable laboratory and data services to support clinical trials and drug development worldwide. Its offerings include central and specialty bioanalytical testing, radiopharmaceutical support, decentralized/near-home collection, custom collection kits and high-volume kitting, companion diagnostics and assay validation, data management and harmonization, regulatory and scientific project management, and commercial/post-market support. LabConnect serves sponsors and CROs across multiple therapeutic areas (oncology, vaccines, cell and gene therapy/ATMPs and more), emphasizing program oversight and operational execution for clinical research.

📋 Description

• Execute internal and external audits • Support vendor and client audits • Drive post-audit actions to completion • Assist Quality Management in monitoring GCP regulatory compliance and quality in clinical trial operational activities • 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 • 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 • Track, trend, and monitor audit and compliance actions in support of the global QMS • Compose routine correspondence to internal and external stakeholders • Organize and maintain electronic and hard-copy files and records • Conduct research and prepare statistical reports • Coordinate meetings, prepare agendas, arrange facilities, and record and transcribe minutes • Perform quality system assessments for continuous improvement initiatives • Train new hires on job-specific duties as appropriate • Act as QRS representative in internal and external meetings with stakeholders and clients • Organize, maintain, and archive quality records in accordance with document control and retention requirements • Support the eQMS through 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 • Maintain quality logs, metrics, and dashboards for management review, audits, and continuous improvement • Perform other related duties assigned by Quality Management

🎯 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 • Prolonged periods of sitting at a desk and working on a computer • Prolonged use of computer and headphones for conference calls • Ability to communicate effectively via phone, video, and email • Close vision, color vision, depth perception, and ability to adjust focus • Ability to use hands and fingers to operate a computer and other office equipment • Ability to walk and/or reach with hands and arms • Ability to read text of various sizes • Ability to communicate with others and hear • Ability to lift, pull and/or push up to 25 pounds

🏖️ Benefits

• Fully remote role • Up to 25% travel