Francesca Isetta Email & Phone Number

Brampton, Ontario, Canada

Bramalea, Ontario

Prepared, distributed and maintained documents generated by the Analytical Operations Research & Development Dept. such as technical reports, methods, analytical procedures, Certificates of Analysis, flow charts, Compendia & Specifications correspondence and PowerPoint presentationsCreated new methods and procedures, using Content 7.0, for submission of new drug products for approval in local and international markets and for tech transfers to commercialPrepared CCF’s for method and SOD revisionsIssued monthly progress reports; presented by the Specification & Technical Transfer Manager to update the Executive CommitteeCreated Access database, including entry forms and reports, for compendial specifications history/updatesMaintained strict compliance with GMP/GLP, SOPs, SWPs, Good Documentation Practices

GMP Compliance team member; verified and approved calibration and maintenance activities and reports on all lab equipment Created and revised SODs for Lab Technical Services Department

Member of Compliance Readiness Team for Scientific Affairs Division – SOD project for revising and converting Interleaf documents into Bladerunner formatCreated and revised existing Bladerunner format SODsDeveloped new tri-level SODs for multiple companiesRecreated and revised SOD exhibits and images using Visio softwarePrepared CRF’s and CCF’s for SOD revisions

Created my own home- business making wedding and special occasion cakes, chocolates and fancy desserts. Specialized in Sugar Artistry, creating flowers and cake decorations.

Team member for the validation of the USP (Reverse Osmosis) water system, ensuring water quality for production of Coppertone Sun products, Muskol, Correctol and Dr. Scholl products. Scheduled and performed all quality control testing for raw materials and finished products within established work schedules. Prepared and validated all media required for product testing. Set up and maintained bacterial and yeast cultures required for media quality control. Coordinated and performed all environmental monitoring for the plant and submit monthly reports. Created and revised SODs for Quality Assurance Department. Responsible for purchasing all materials required in the microbiology lab. Researched and submitted justification requests for purchasing major pieces of equipment. Performed TLC and HPLC testing in the chemistry lab.

Performed plate counts, microbiological antibiotic assays and sterility testing on all raw materials and finished products, ensuring results within tight timelines.Prepared media required for microbial product testing.

University Co-op and full-time.Developed and completed validation project for new media to be used in Environmental Monitoring. Coordinated product testing with the Planning department, and scheduled and assigned testing of products. Coordinated and performed Environmental Monitoring, and submitted monthly reports. Document reviewer for microbiology lab. Created and validated all the SOD's for the set-up and maintenance of each individual frozen bacterial, yeast and mold culture that was used for assays and media quality control. Performed manual and automated antibiotic assays, thin-layer chromatography, U. V. assays and additional testing for raw materials, finished product, stability and validation samples within established work schedules.

B.Sc., Microbiology

Project Management Certification, Project Management - Pt/In Progress

Chemical Microbiological Technologist Diploma, Industrial Microbiology