Title: QA Data Steward
Duration: 12 month contract, possibility of extension
Location: Durham, NC
Position Description
The QA Data Steward (Contractor) supports the QA-for-QC organization by performing quality-
related activities and Computer System Validation (CSV) tasks for QC laboratory computer systems.
This role is responsible for supporting QA computer systems used by QC laboratories, including
Darwin and future-state LabVantage LIMS, to ensure systems remain compliant, validated, and
operationally effective.
The contractor performs defined quality system activities related to computerized systems, including
CSV execution, master data management, and support of system-related investigations and
remediation activities. This role requires strong understanding of GMP, data integrity principles, CSV
expectations, and QC laboratory workflows. While the contractor performs quality and CSV activities,
final quality decision-making authority remains with QA leadership unless otherwise designated.
Key Objectives/Deliverables
CSV / QA Computer System Support
• Perform CSV activities for QC laboratory systems, including execution of validation test
scripts, data verification, and evidence generation.
• Support lifecycle management of QA computer systems used by QC, including system
changes, upgrades, and periodic review activities.
• Support quality system activities related to computerized systems, including minor
investigations, discrepancy documentation, and remediation support.
• Support inspection readiness for QC systems by preparing validation and system evidence
packages.
LIMS (Darwin / LabVantage)
• Create, revise, and maintain LIMS master data (specifications, methods, materials,
instruments, workflows, user configurations).
• Support cross-functional review of documents required for master data setup and system
configuration.
• Troubleshoot master data or configuration issues and support system migration or
implementation activities (e.g., Darwin to LabVantage).
Operational Support
• Collaborate with QC, TS/MS, QA-for-QC, and IT on QC laboratory system activities and
updates.
• Support planning, prioritization, and communication of system and master data activities
impacting QC laboratories. Compliance & Documentation
• Follow GMP, data integrity, and documentation requirements for all activities performed.
• Maintain training compliance and documentation accuracy.
• Provide system and validation data to support audits and inspections.
Requirements (Education, Experience, Training)
• Bachelor’s degree in computer science, engineering, science, or relevant technical field, or
equivalent experience.
• Minimum 3 years of experience supporting GMP computer systems in a pharmaceutical or
medical device environment.
• Experience performing or supporting CSV activities for QC-related systems.
• Basic understanding of QC laboratory processes, analytical testing workflows, and data
integrity principles.
• Strong attention to detail with understanding of electronic records and data structures.
Preferred Attributes (Not Required)
• Experience specifically with Darwin and/or LabVantage LIMS.
• Experience with SAP, TrackWise, Veeva QDocs, LES, or instrument data systems.
• Familiarity with CSV documentation, testing execution, and system remediation activities.
• Strong interpersonal, communication, and technical writing skills.
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