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.
Job Summary
The Quality Specialist II role is responsible for planning, conducting, and reporting audits to ensure compliance with GCP guidelines, regulatory requirements, and internal quality standards across clinical research activities.
This role requires onsite presence in Johnson City, TN three days per week, with the flexibility to work remotely for the remaining two days. It is best suited for candidates within commuting distance to this location.

Essential Duties and Responsibilities

• Plan, schedule, and execute GCP audits (e.g., investigator sites, vendors, systems, and internal processes)
• Track and follow up on audit findings and CAPAs to ensure timely resolution
• Prepare detailed audit reports and issue audit certificates
• Monitor and assess compliance with ICH-GCP, FDA, EMA, and sponsor-specific requirements
• Support the development and implementation of quality management systems and SOPs related to central lab operations and clinical trial support
• Participate and support in the identification and assessment of quality risks and advise on mitigation and controls
• Performs document control activities using Veeva Vault, including but not limited to SOP creation, revision, obsolescence, and/or approvals
• Support inspection readiness and participate in sponsor or regulatory inspections
• Participate in the qualification and quality oversight of vendors supporting clinical trials
• Provide GCP guidance to internal teams and external partners
• Analyze quality metrics and trends to identify areas for improvement
• Maintain up-to-date knowledge of evolving GCP regulations and industry best practices
• Performs frequent assessments of the quality system for continuous improvement initiatives
• Trains new hires on job specific duties and regulatory standards as deemed appropriate
• Performs other related duties and tasks as necessary or as assigned by Quality Management

Education and Experience

• Bachelor’s or master’s degree in life sciences, pharmacy, nursing, or a related field
• 5+ years quality-related roles, specializing in regulatory compliance and document management, with at least 3+ years in auditing or 3 years quality-related roles, specializing in regulatory compliance and document management, with at least 3 years in auditing with graduate degree.
• Strong knowledge of ICH-GCP, FDA, EMA, and other global regulatory frameworks
• Strong organizational, communication, and report-writing skills, ensuring clarity in professional communication and audit responses
• Experience with electronic quality systems (e.g., Veeva, eQMS. eDMS)
• Ability to work independently and collaboratively, balancing multiple projects

Skills and Ability

• Experience auditing internal stakeholders and/or third-party vendors
• Familiarity with CAPA management and audit lifecycle documentation
• Certification in quality or auditing (e.g., RQAP-GCP, ASQ-CQA, ISO)

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 and discover how your work can impact patients’ lives around the world!

Essential Duties and Responsibilities

• Plan, schedule, and execute GCP audits (e.g., investigator sites, vendors, systems, and internal processes)
• Track and follow up on audit findings and CAPAs to ensure timely resolution
• Prepare detailed audit reports and issue audit certificates
• Monitor and assess compliance with ICH-GCP, FDA, EMA, and sponsor-specific requirements
• Support the development and implementation of quality management systems and SOPs related to central lab operations and clinical trial support
• Participate and support in the identification and assessment of quality risks and advise on mitigation and controls
• Performs document control activities using Veeva Vault, including but not limited to SOP creation, revision, obsolescence, and/or approvals
• Support inspection readiness and participate in sponsor or regulatory inspections
• Participate in the qualification and quality oversight of vendors supporting clinical trials
• Provide GCP guidance to internal teams and external partners
• Analyze quality metrics and trends to identify areas for improvement
• Maintain up-to-date knowledge of evolving GCP regulations and industry best practices
• Performs frequent assessments of the quality system for continuous improvement initiatives
• Trains new hires on job specific duties and regulatory standards as deemed appropriate
• Performs other related duties and tasks as necessary or as assigned by Quality Managemen

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