Senior QA Specialist - Computer Systems & Data Integrity

Labconnect,-LL; Oakland Village (TN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health Benefits beginning on date of/h

PTO plan and 11 paid holidays

Disability Insurance

Life Insurance

401k Match

Career growth opportunities

Job summary

LabConnect is seeking a Senior Quality Assurance Specialist focusing on Computer System Validation and data integrity within GxP environments. You will ensure that computerized systems are validated, compliant with FDA 21 CFR Part 11 and EU Annex 11, and that data integrity principles are upheld throughout the system lifecycle.

You will lead audits, support CAPAs, manage risk assessments, and maintain SOPs while collaborating with IT, QA, and regulatory teams to drive continuous improvement and

Qualifications

• Bachelor’s degree in information technology or related field with strong regulatory exposure.
• 6+ years of relevant experience in regulated settings (FDA 21 CFR 11, Annex 11, ISO27001, SOX, HIPAA, etc.).
• Preference for recognized IT auditor certifications (CISA, CISSP, ISO27001 Lead Auditor).

Responsibilities

• Oversee CSV activities for new and modified systems across the software life cycle.
• Plan and perform IT vendor audits and assess validation reports for gaps and risks.
• Prepare risk assessments and contribute to CAPA development and implementation.
• Create and maintain SOPs for regulatory compliance of computerized systems.
• Support data integrity initiatives and regulatory compliance documentation.

Skills

Regulatory compliance

Quality Assurance

Audit management

Risk assessment

Documentation

Education

Bachelor’s degree in information technology or related field

Tools

Veeva Vault

LIMS

Job description

LabConnect is seeking a Senior Quality Assurance Specialist focusing on Computer System Validation and data integrity within GxP environments. You will ensure that computerized systems are validated, compliant with FDA 21 CFR Part 11 and EU Annex 11, and that data integrity principles are upheld throughout the system lifecycle.

You will lead audits, support CAPAs, manage risk assessments, and maintain SOPs while collaborating with IT, QA, and regulatory teams to drive continuous improvement and