Senior QA Specialist – Computer Systems & Data Integrity

LabConnect; Oakland Village (TN); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health benefits

401k match

Paid time off

Education assistance

Job summary

LabConnect in Johnson City, TN, seeks a Senior Quality Assurance Specialist focused on Computerized Systems Validation and Data Integrity to join a regulatory-compliant team. You will lead CSV activities, audits, CAPAs, and risk assessments across GxP systems in a fast-paced environment.

Ideal candidates have a BS in IT or related field, 6+ years in regulated settings (FDA 21 CFR Part 11, Annex 11, ISO27001), strong attention to detail, and experience with Veeva Vault and LIMS.

Qualifications

• Bachelor’s degree in information technology or related field, with 6 years of relevant experience in regulated environments.
• Experience in clinical trials, biotech, or pharma with focus on computerized systems and regulatory compliance.
• Preferred: IT auditor certifications (CISA, CISSP, ISO27001 Lead Auditor) or equivalent.

Responsibilities

• Oversee Computer System Validation activities across the system lifecycle, ensuring compliance with FDA 21 CFR Part 11 and EU Annex 11.
• Plan and perform IT vendor audits, review validation reports, and participate in CAPA activities.
• Assist with risk assessments of new technologies and contribute to data integrity strategies.
• Create and maintain SOPs for regulatory compliance related to computerized systems and data privacy.

Skills

Attention to detail

Regulatory compliance

Auditing

Cross-functional collaboration

Problem solving

Communication

Education

Bachelor's degree in information technology or related field

Tools

Veeva Vault

LIMS

Job description

LabConnect in Johnson City, TN, seeks a Senior Quality Assurance Specialist focused on Computerized Systems Validation and Data Integrity to join a regulatory-compliant team. You will lead CSV activities, audits, CAPAs, and risk assessments across GxP systems in a fast-paced environment.

Ideal candidates have a BS in IT or related field, 6+ years in regulated settings (FDA 21 CFR Part 11, Annex 11, ISO27001), strong attention to detail, and experience with Veeva Vault and LIMS.