Quality Systems Specialist I
Quality Systems Specialist I
Roles and Responsibilities
• Conducts a comprehensive and critical evaluation of Laboratory records in support of commercial product release. Analyses to be conducted on the execution of techniques such as Titrations, Karl Fischer, UV-Vis/Fluorometer, pH/Conductivity, HPLC, GC, and Ion Chromatography. This evaluation includes, but is 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 review of contract laboratory testing
• Supports the generation of Quality Metrics and Reports
• Performs procedural and method revisions, where necessary.
• Conducts GMP review of QC laboratory records, logbooks and associated forms including electronic raw data to ensure compliance with Gilead's data integrity policy.
• Supports OOS/OOT investigation and CAPA implementation
• Assists in the laboratory method and/or instrumentation validation activities.
• Conducts off hour (early morning/late night/weekends) data review to support production needs.
• Participates in validation and commercial/developmental manufacturing activities as required
• May support on-the-job training for new team members
- Bachelor's degree in Chemistry or related discipline
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) related to cGMP in the Manufacturing of Pharmaceuticals
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, USP, GLP, and cGMP regulations
- Proficient in MS Word, Excel, Power Point and other applications
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
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