Continued with responsibilities in the role described prior to this one.Additionally, also a quality contact liaison for Bora working with GSK.

Stability / Operational Quality Specialist/ Regulatory Compliance- Extremely organize and proactive, managed timelines extremely well.- Able to manage several projects simultaneously- Experience in Change Control, Regulatory Compliance; Batch Review and Release; PPRs; Deviations, Complaints.- Write/Review/approve documents including SOPs, stability protocols/reports, PBRs, BOMs, CDisy, eBRS, Freeweigh, etc.- Prepared/ contributed to US FDA Annual changes reports.- contributed to preparations and reviews of EU/ROW/Intl’l / Japan submission dossiers/ conformance guides working with international teams using electronic submission database.- Participated in internal and external audits as a subject matter expert.- Worked on several Process improvements projects.

Stabililty Program Management and Analytical Review of Finished Products, Stability Studies and Raw Materials- Write/Review/approve documents including SOPs, stability protocols/reports, etc.- Supervise QC Review and Release Team.- Supervise and manage the Retain/Reserve sample inventory program.- Supervised/Coordinate management of the Commercial Ongoing Stability Program in accordance with registered details, GMPs, ICH and FDA guidelines.- experience with Interview and selection of hires; conduct performance reviews.- Prepare/ contribute to US FDA Annual Stability reports using electronic submission database.- Participates in internal and external audits as a subject matter expert.- Work on several Process improvements projects.

Progressed from Analyst, testing material and finished goods to coordinating Lab activities.Supervised the Raw Material Lab.