Quality System Specialist II Replacement Wednesday through Saturday Swing Shift 1pm - 12am; (4 x 10 Schedule) Specific Responsibilities Conducts a comprehensive and critical evaluation of laboratory records including but not limited to content, results, data accuracy and scientific relevance, format and adherence to GMP.Performs a thorough review of raw data and documentation to ensure compliance to applicable specifications and protocols. Supports the laboratory testing group instrument qualification and method validation review. Performs procedural and method revisions, where necessary. Conducts GMP review of laboratory notebooks, logbooks and associated forms including electronic raw data to ensure compliance with Gilead's data integrity policy. Supports OOS/OOT investigation and CAPA implementation. Conducts off hour (early morning/late night/weekends) data review to support production needs. Provides new hire training. Specific Required Skills Advanced knowledge of current Good Manufacturing Practices (GMPs), pharmacopeia and compendial requirements, and pharmaceutical industry practices. Strong knowledge of regulatory requirements surrounding Data Integrity. Familiarity of analytic testing methods and validation including laboratory instrumentation. Ability to apply critical thinking and good judgment. Strong organizational and problem solving skills. Strong verbal, written, and interpersonal skills are required. Proficiency in Microsoft Office and laboratory computerized systems such as Empower and LIMS.
