Quality Systems Specialist - II

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.