Senior QA Lead - Computer Systems & Data Integrity

LabConnect; Johnson City (TN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401k Match

Health Benefits

PTO and Holidays

Disability/Life Insurance

Career growth opportunities

Job summary

LabConnect in Johnson City, TN, seeks a Senior Quality Assurance Specialist to validate and maintain GxP computerized systems and uphold data integrity across the system lifecycle.

The role requires staying current with FDA 21 CFR Part 11, EU Annex 11, and related regulations, contributing to risk assessments, CAPAs, audits, and vendor qualification, with cross-functional collaboration.

Qualifications

• Bachelor's degree in information technology or related field and 6+ years in regulated environments.
• Experience with FDA 21 CFR Part 11, Annex 11, ISO 27001 and related standards.

Responsibilities

• Oversee Computer System Validation activities across full software life cycle.
• Plan and perform IT vendor audits and review validation reports.
• Contribute to risk assessments and CAPA planning.
• Develop and maintain SOPs for regulatory compliance of computerized systems.
• Manage documentation for CSV and data integrity projects.
• Support IT questionnaires, audits, and internal reviews.
• Ensure life cycle governance of GxP systems through QMS processes.

Skills

Regulatory compliance knowledge

CSV/quality systems

IT auditing

Data integrity

GxP knowledge

Education

Bachelor's degree in information technology or related field

Tools

Veeva Vault

LIMS

MS Office

Job description

LabConnect in Johnson City, TN, seeks a Senior Quality Assurance Specialist to validate and maintain GxP computerized systems and uphold data integrity across the system lifecycle.

The role requires staying current with FDA 21 CFR Part 11, EU Annex 11, and related regulations, contributing to risk assessments, CAPAs, audits, and vendor qualification, with cross-functional collaboration.