Description:

　　The Specialist I, Lab Compliance - QC is responsible for developing, managing, and implementing the laboratory compliance and data integrity program for the site to ensure compliance with local and global regulatory agency requirements, internal company standards, and current industry practices. This role will support overall laboratory compliance including but not limited to GLP, GxP, Data Governance/Integrity programs for site laboratory operations (sample receipt through sample disposition) and all laboratory systems as prescribed in Global Quality Standard (GQS) policies and site standard operation procedures across system validation lifecycles for assurance with regulatory and compliance requirements.

　　Essential Functions:

　　Perform periodic review of electronic data and audit trail of chromatographic and non-chromatographic systems. Review Aborted and Altered sample set in chromatographic systems audit trail for proper comments and same notation in the laboratory notebook.

　　Perform periodic review of laboratory analysis for completeness, specification compliance, and data integrity with company’s written policies. Report any abnormal findings to their Supervisor. As assigned, perform in-depth review of analytical records/reports including laboratory notebook, chromatograms, and audit trails to assure that calculations and other data are technically correct and compliant to relevant specifications.

　　Perform periodic auditing of the laboratory systems (sample management, stability program, metrology program, glassware management; reference standard, chemicals, and column management, etc.)

　　Actively participate in process improvement initiatives aiming for Right First Time (RFT) on documentation and deviation reduction in collaboration with Quality Management teams

　　Perform periodic auditing of the laboratory investigations (unplanned deviations, OOALs/ OOTs, and incidents) to ensure investigations are carried out in accordance with he applicable SOPs/guidance.

　　Continuously improve data integrity knowledge base and understanding: Identify training needs, and ensure availability of appropriate and functionally relevant training materials; where training does not exist, facilitate creation of material and delivery of training