Quality Audit Specialist

🔥 3 minutes ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

💻 IT Support

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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

• 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 files 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.

🎯 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)