Senior Quality Specialist

LabConnect•Johnson City, TN

2d•Onsite

About The Position

The Senior Quality Specialist is responsible for assisting Quality Leadership with ensuring compliance and quality processes are maintained in support of clinical trial operational activities. The Senior Quality Specialist will serve as chief administrator for the quality management software (QMS) and is responsible for development, configuration and management of the QMS.

Requirements

4 -year degree preferred with 5-7 years of Quality Assurance Experience; or a 2-year degree with 8-10 years related experience and/or training; or equivalent combination of education and experience.
Must possess strong organizational and interpersonal skills.
Experience with QMS platforms such as Veeva is highly preferred.
Proven track record of leading QMS implementations or enhancements is a strong asset.

Nice To Haves

Veeva Belt certification preferred.

Responsibilities

Leads and project manages QMS activities including document control, change control, non-conformance reporting and supplier qualification/requalification
Serves as team lead CSV specialist
Responsible for data reduction, metrics and managerial reports delivery
Supervise and assist in management of QMS Non-Conformance reporting and their related investigation, root cause analysis, proposed corrective and/or preventive measures, and due diligence thereto
Trains QMS users on workflow and associated tasks for modules within the QMS
Leads eQMS configuration and improvement specialist
Assesses, creates, and presents QMS Lean and Process Efficiency opportunities and projects
Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating, conducting and documenting QMS module gap analyses
Provide industry leading QMS compliance guidance and quality assurance consultation to internal and external stakeholders
Clear and concise communication of QMS reporting for regulatory and quality consulting advisements
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 and types statistical reports
Performs other tasks as defined by the Quality Assurance Leadership