Senior Quality Specialist

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.

About the Role

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.

Essential Duties And Responsibilities

• Serves as team lead CSV specialist
• Trains QMS users on workflow and associated tasks for modules within the QMS
• Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating, conducting and documenting QMS module gap analyses
• Clear and concise communication of QMS reporting for regulatory and quality consulting advisements
• Schedules and conducts monthly quality review meetings as required
• 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

Education And Experience

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. Veeva Belt certification preferred.

Skills And Ability

• 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

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.

Join Our Team

Discover how your work can impact patients' lives around the world! Some of the Perks our LabConnectors Love: 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 We celebrate our differences, which enriches our culture! In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always. We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here: here. To learn more, please review our Privacy Notice on our website, by navigating to here.