Quality Specialist I

The Quality Specialist I is responsible for assisting Quality Management in monitoring GCP regulatory compliance and quality in clinical trial operational activities. The Quality Specialist I role will frequently interact with cross-functional groups and external partners to ensure compliance initiatives are met. Essential Duties and Responsibilities Assists in scheduling and organizing internal and external assessments of LabConnect by QRS or Clients.

Schedules and performs internal assessments including, but not limited to, computer systems validations, equipment calibration and validation review, internal audits, study set-up QC, directed inspections and investigations, gap analyses, etc. Performs remote assessments of LabConnect vendors on a risk-based schedule. Updates and maintains QRS Key Performance Indicators and other metrics as necessary for assuring timely decision making and Management review.

Participates in the maintenance of the eQMS including issuing, creating and reviewing documents in overall support of continuous improvement. Assists Project Managers and operational management with quality and regulatory advisement when required. Actively participates in root cause analyses and defining corrective and preventative actions for nonconformances or quality related issues that are reported. Tracks, trends and monitors actions pertaining 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; 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. Composes timely routine correspondence to internal and external stakeholders.

Coordinates and arranges meetings, prepares agendas, reserves and prepares facilities, and transcribes minutes of meetings for delivery. Performs other duties as assigned. Education and Experience Bachelor’s degree (B.S./B.A.) preferred; and 1-2 years of related experience and/or training; or equivalent combination of education and experience. Skills and Ability 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. Supervisory Responsibilities: None Physical Demands: While performing the duties of this job, the occupant is regularly required to: Prolonged periods of sitting at a desk and working on a computer. Prolonged use of computer and headphones for conference calls. Communicate effectively via phone, video, and email. Use hands and fingers to operate a computer and other office equipment.

Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus. Walk and/or reach with hands and arms. Read text of various sizes. Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus. Communicate with others and hear. Lift, pull and/or push up to 25 pounds. Travel Requirements: Minimal