Senior Quality Specialist

LabConnect • Johnson City, TN

1d • Onsite

About The Position

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 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

Benefits

• Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
• Health Benefits beginning on date of hire
• PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
• Short and Long-Term Disability, Life Insurance, and AD&D

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree