Quality Specialist I

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

📋 Description

• Support the Quality Management team in overseeing GCP regulatory compliance and ensuring quality in clinical trial operations.

• Arrange and coordinate internal and external LabConnect evaluations conducted by QRS or clients.

• Organize and execute internal evaluations, which include computer systems validation, equipment calibration and validation review, audits, study set-up quality control, inspections, investigations, and gap analyses.

• Conduct risk-based remote evaluations of LabConnect vendors.

• Update and oversee QRS key performance indicators and other relevant metrics.

• Engage in the upkeep of the electronic Quality Management System (eQMS), which involves creating, reviewing, issuing, revising, and controlling quality documents.

• Provide guidance to project managers and operational management on quality and regulatory issues.

• Take part in root cause analyses and determine corrective and preventive actions for nonconformities and quality concerns.

• Monitor, track, and analyze nonconformance reports, customer complaints, audit results, and document change control.

• Organize, maintain, and archive both electronic and hard-copy quality records.

• Draft routine correspondence for both internal and external stakeholders.

• Coordinate meetings, prepare agendas and venues, and document meeting minutes.

• Carry out other assigned responsibilities.

⛳️ Requirements

• Bachelor’s degree (B.S./B.A.) preferred; along with 1-2 years of relevant experience and/or training; or an equivalent combination of education and experience.

• Exceptional attention to detail, planning, and problem-solving abilities.

• Strong organizational and time management capabilities.

• Excellent listening and verbal comprehension skills for effective professional communication and audit preparedness.

• Capability to make informed decisions and adjust to evolving environments and requirements.

• Self-motivated with the ability to work independently as well as collaboratively.

• Competence in adhering to established timelines, processes, and procedures.

• Ability to manage multiple projects while maintaining attention to detail.

• Capacity to sit for extended periods and work on a computer.

• Proficient in using computers, headphones, phones, video conferencing, email, and office equipment.

• Ability to lift, pull, and/or push up to 25 pounds.

🏝️ Benefits

• Minimal travel requirements.