QA/CSV Data Steward

ABOUT THE ROLE Our client is seeking a QA Data Steward to join their QA-for-QC organization in Durham, NC. This 12-month contract role, with the possibility of extension, is responsible for supporting quality-related activities and Computer System Validation (CSV) tasks for QC laboratory computer systems. The QA Data Steward will ensure that systems such as Darwin and LabVantage LIMS remain compliant, validated, and operationally effective. The role involves executing CSV activities, managing master data, supporting system investigations and remediation, preparing validation evidence for inspection readiness, and collaborating with cross-functional teams. The ideal candidate will have a strong understanding of GMP, data integrity principles, CSV expectations, and QC laboratory workflows, and will play a key part in maintaining the integrity and compliance of critical laboratory systems. WHAT YOU'LL DO Perform Computer System Validation (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. Prepare validation and system evidence packages to support inspection readiness for QC systems. 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). 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. 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. Ensure all activities are performed in accordance with company policies and regulatory requirements, with final quality decision-making authority remaining with QA leadership unless otherwise designated. WHAT YOU BRING 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 Computer System Validation (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. Experience with Darwin and/or LabVantage LIMS (preferred). Experience with SAP, TrackWise, Veeva QDocs, LES, or instrument data systems (preferred). Familiarity with CSV documentation, testing execution, and system remediation activities (preferred). Strong interpersonal, communication, and technical writing skills. Ability to work collaboratively with cross-functional teams and manage multiple priorities in a fast-paced environment. Commitment to maintaining training compliance and documentation accuracy. Job Type: Contract Pay: From $45.00 per hour Expected hours: 40 per week Benefits: Dental insurance Health insurance Vision insurance Application Question(s): How many years of experience do you have supporting GMP Computer systems within a pharmaceutical or medical device environment? Are you currently located near the Durham, NC area? Work Location: In person