Quality Specialist I

LabConnect•Johnson City, TN

13d

About The Position

The Quality Specialist I assists Quality Management in monitoring GCP regulatory compliance and quality in clinical trial operational activities. The role frequently interacts with cross-functional groups and external partners to ensure compliance initiatives are met. The specialist supports assessments, audits, investigations, quality metrics, document control, the electronic Quality Management System (eQMS), corrective and preventive actions, and quality-related advice for project and operational teams. The position has minimal travel and no supervisory responsibilities.

Requirements

Bachelor’s degree (B.S./B.A.) preferred, and 1–2 years of related experience and/or training, or an equivalent combination of education and experience.
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-considered decisions and adapt to changing environments and requirements.
Self-motivation and ability to work independently as well as collaboratively.
Ability to adhere to established timelines, processes, and procedures.
Ability to work independently and collaboratively while balancing multiple projects with attention to detail.
Ability to perform prolonged periods of sitting at a desk and working on a computer; use a computer and headphones for conference calls; communicate via phone, video, and email; operate a computer and other office equipment; walk and/or reach; read text of various sizes; communicate with others and hear; and lift, pull, and/or push up to 25 pounds.
Specific vision abilities include close vision, color vision, depth perception, and ability to adjust focus.

Responsibilities

Assist in scheduling and organizing internal and external assessments of LabConnect by QRS or clients.
Schedule and perform internal assessments, including computer systems validations, equipment calibration and validation review, internal audits, study set-up QC, directed inspections and investigations, and gap analyses.
Perform remote assessments of LabConnect vendors on a risk-based schedule.
Update and maintain QRS Key Performance Indicators and other metrics to support timely decision-making and management review.
Participate in maintaining the eQMS, including creating, issuing, reviewing, revising, and controlling quality documents in support of continuous improvement.
Assist Project Managers and operational management with quality and regulatory advice when required.
Participate in root cause analyses and define corrective and preventive actions for reported nonconformances or quality-related issues.
Track, trend, and monitor actions related to non-conformance reporting, customer complaints, internal and external audit findings, and document change control.
Organize, maintain, and archive electronic and hard-copy quality records in accordance with document control and record retention requirements, ensuring accurate filing, traceability, and accessibility.
Compose timely routine correspondence to internal and external stakeholders.
Coordinate and arrange meetings, prepare agendas, reserve and prepare facilities, and transcribe and deliver meeting minutes.
Perform other duties as assigned.