Senior Quality Specialist

Remote - US, 2304 Silverdale Drive, Johnson City, Tennessee, United States of America

Posted Tuesday, July 21, 2026 at 7:00 AM

Lab Connect 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.

• Leads and project managesQMSactivitiesincluding document control, change control, non-conformancereportingand supplier qualification/requalification
• Serves as team lead CSV specialist
• Responsible for data reduction,metrics and managerial reports delivery
• Supervise andassistin management ofQMSNon-Conformance reporting and their relatedinvestigation, root cause analysis, proposed corrective and/orpreventive measures,and due diligence thereto
• TrainsQMS users on workflow and associated tasks for modules within the QMS
• LeadseQMSconfiguration and improvement specialist
• Assesses, creates, and presentsQMSLean and Process Efficiency opportunities and projects
• Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating,conducting and documentingQMS modulegap analyses
• Provide industry leadingQMScompliance guidance and quality assurance consultation to internal and external stakeholders
• Clear and concise communication ofQMSreporting for regulatory and quality consulting advisements
• Schedules and conducts monthly quality review meetings as required
• Prepare training materials and conduct training for QMStopics
• Collaborates with Human Resourcesregardingtraining program requirements affected by the QMS
• Serves as Quality subject matter expert for configurable systems validation projects
• Conducts research, and compiles andtypesstatistical reports
• Performs other tasks as defined by the Quality Assurance Leadership

• 4
  -year degree preferred with5-7years of Quality Assurance Experience; ora 2-year degree with8-10yearsrelated experience and/or training; or equivalent combination of education and experience.

• Mustpossessstrong organizational and interpersonal skills.
• Experience with QMS platforms such as Veeva is highly preferred.
• Proven track recordof leading QMS implementations or enhancements is a strong asset.

None

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.

Minimal

Join our team and discover how your work can impact patients' lives around the world!

• 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 viewthe posters here:https://(Use the "Apply for this Job" box below)./posters

Lab Connect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website, by navigating to

Remote - US, 2304 Silverdale Drive, Johnson City, Tennessee, United States of America