Julia Gianino Email & Phone Number

Fremont, Ca, Us

Fremont, Ca, Us

• Reviewed and identified improvement opportunities in the current stability program and implemented changes to the program management process. • Contributed to internal audit activities as a trained auditor on the Internal Audit Committee.

United States

• Conducted Out-of-Specification investigations and performed root cause analysis for stability testing. • Authored and reviewed stability reports, SOPs, and other controlled quality documents to improve an existing procedure and ensure compliance with regulatory requirements.• Authored 16 training procedures for trainers to follow and established a training system to enhance competency-based training for QC product release and stability analyst role to standardize the training process and reduce skill gaps.• Standardized stability report formats and electronic result templates to optimize productivity.• Championed validated sample range calculation spreadsheet while establishing a new process in stability study for a newly developed assay platform.

San Diego, California, United States

• Prioritized the monthly stability schedule and planned testing accordingly to deliver quality results on time as the primary operator to perform all stability testing.• Trained QC analysts in technical skills required for product release testing. • Created electronic inventory spreadsheet and applied 6S methodology to improve organization and traceability of stability programs' material and sample inventories.• Organized 6S activities as a facilitator for the department and improved QC laboratory area audit compliance score average by 15% for the bi-weekly interdepartmental internal audits.

San Diego, California

• Performed quality control testing for components, raw materials, and in-process commercial product release following appropriate SOPs.• Applied GDP for all records and achieved excellent document accuracy.• Performed routine maintenance of laboratory equipment to ensure cGMP compliance is up to date and properly documented.• Actively participated in Continuous Improvement and 6S programs and implemented CI ideas to improve standardization and organization in the laboratory area.