Senior Quality Specialist - Quality & Regulatory Systems

Overview

LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.

We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.


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

This position is ideally suited for candidates within commuting distance to Johnson City, TN or in the Eastern US time zone.

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


Education/Experience

4 -year degree preferred with 5-7years 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.


Language Ability

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.


Math Ability

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra, statisticsand geometry.


Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnishedin written, oral, diagram, or schedule form.


Computer Skills

To perform this job successfully, an individual must have working knowledge of Microsoft Office applications, including word processing software, spreadsheet software, MS PowerPoint, and MS Project. Additional experience with eQMS, eLMS, document control and other industry software preferred.


Certificates and Licenses

Veeva Belt certification preferred.


Supervisory Responsibilities

This job does not have supervisory responsibilities.


Work Environment

The noise level in the work environment is usually moderate.


Physical Demands

While performing the duties of this job, the employee is regularly required to sit. The employee is frequently required to talk or hear. The employee