Senior Quality Specialist

Labconnect International Ltd•Johnson City, TN

22d•Hybrid

About The Position

The Quality Specialist, Sr. is responsible for assisting Quality Leadership with ensuring compliance, optimizing quality processes, and implanting strategic enhancements of the Quality Management System (QMS) in support of clinical trial operational activities. The Quality Specialist, Sr. will serve as administrator for the quality management software (QMS) and is responsible for development, configuration, and management of the QMS. Please note: this is a hybrid role and requires 2-3 days per week of onsite presence at our office in Johnson City, TN.

Requirements

2-year Associate degree with 8-10 years related experience and/or training required, or
4 -year bachelor s degree preferred with 5-7 years of Quality Assurance Experience
Must possess strong organizational and interpersonal skills.

Nice To Haves

Experience with QMS platforms such as Veeva is highly preferred.
Proven track record of leading QMS implementations or enhancements is a strong asset.

Responsibilities

Leads and project manages QMS activities, ensuring robust implementation and continuous improvement of document control, change control, non-conformance reporting, and supplier qualification/requalification processes within the QMS framework.
Serves as team lead, in a non-supervisory capacity, on QMS-related systems, ensuring compliance with regulatory standards
Responsible for QMS metrics and reporting to leaders across the company
Supervise and assist in management of QMS Quality Event reporting and related investigation, root cause analysis, proposed corrective and/or preventive measures, and timely closure
Trains QMS users on workflow and associated tasks for modules within the QMS
Leads configuration, optimization, and continuous improvement initiatives for electronic QMS (eQMS), ensuring alignment with organizational quality objectives and regulatory requirements
Identifies and drives QMS-centric Lean and process efficiency initiatives, leveraging data analytics and stakeholder input to enhance system performance and user experience
Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating, conducting and documenting QMS module gap analyses
Provide expert-level QMS compliance guidance and strategic quality assurance consultation to internal teams and external partners, ensuring adherence to industry best practices and regulatory expectations.
Schedules and conducts monthly quality review meetings as required.
Prepare training materials and conduct training for QMS topics.
Collaborates with Human Resources regarding training program requirements affected by the QMS.
Serves as Quality subject matter expert for configurable systems validation projects.
Conducts research and compiles reports.
Performs other tasks as defined by the Quality Assurance Leadership