Quality Specialist I

LabConnect•Johnson City, TN

12d

About The Position

The Quality Specialist I assists Quality Management in monitoring GCP regulatory compliance and quality across clinical trial operational activities. The role regularly interacts with cross-functional groups and external partners to ensure compliance initiatives are met. It supports assessments, quality records and the electronic Quality Management System (eQMS), and provides quality and regulatory assistance to project and operational teams. The position also supports continuous improvement by participating in root cause analyses and tracking quality actions. Minimal travel is required.

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 ensure 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 and collaboratively as part of a team.
Ability to adhere to established timelines, processes, and procedures.
Ability to work independently and collaboratively while balancing multiple projects with attention to detail.

Nice To Haves

Bachelor’s degree (B.S./B.A.) is preferred.

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, reviewing, issuing, revising, and change-controlling documents in support of continuous improvement.
Assist Project Managers and operational management with quality and regulatory advisement when required.
Participate in root cause analyses and define corrective and preventative actions for reported nonconformances or quality-related issues.
Track, trend, and monitor actions relating 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 of controlled documents.
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.