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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.
Sprachkenntnisse
- English
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