Diane Dancel
Saylorsburg
Summary
Currently working in a fast-paced environment. Responsible for managing projects to meet business critical timelines. Adaptable to change. Positive, can-do attitude. Proactive, empowered, self-managing, team player with over 20 years of experience at Sanofi.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Principal Scientist, Lead
Sanofi, Inc.
Swiftwater
05.2023 - Current
- Manages Particulate Analysis, Closed Container Integrity Testing (CCIT), Break Loose Glide Force (BLGF) Testing, and Particulate Matter in Injections Testing
- Reviews Particulate Analysis, CCIT, BLGF, and Particulate Matter in Injections Test Results
- Works with Members Across Multiple Departments on Product Launches
- Calculates Reserve and Retention Amounts Based on Required Testing Listed in the Product Specifications
Quality Control Manager
Sanofi Inc.
Swiftwater
12.2016 - 05.2023
- Managed the QC VIMM Stability Team
- Managed the File/Retention Sample Program
- Reviewed Notebooks, Logbooks, Standalone Forms, and Data
- Interpreted Microanalysis Data (i.e. FTIR, SEM/EDS, Raman, Optical, Puncture, Glass Fractures) when needed
- Performed USP Testing for Release and Method Verifications
- Assessed Change Controls
- Wrote and Reviewed SOPs, SWIs, Protocols, Reports, Curricula, Specifications, and Data Packs
- Completed LIMS Queries, MDMs, and Verifications
- Completed Events, Change Controls, and CAPAs
- Attended Meetings and Participated in Process Improvement Initiatives and Inspection Readiness Activities
Quality Control Technician (various levels)
Sanofi Pasteur
Swiftwater
11.2004 - 12.2016
- Performed Isolation of Particulates for Microanalysis
- Photographed Samples and Provided Photography and Puncture Analysis Memos
- Performed Characterizations of Materials
- Performed Interpretation of Particulate Analysis Data and Provided Summary Memos
- Performed Closed Container Integrity Testing
- Performed QC Sample Receiving Tasks
- Performed Initial and Annual Inspections on Retention Samples
- Performed AQL Inspections
- Performed Service Area Tasks
- Performed Inspections on Incoming Component Materials and Filled Containers
Education
Master of Science - Regulatory Affairs/Quality Assurance
Temple University
Fort Washington, PA12.2022
Master of Science - Plant Pathology
Clemson University
Clemson, SC12.1997
Bachelor of Science - Biology/Chemisty
University of Scranton
Scranton, PA12.1992
Skills
- Quality Control
- People Manager
- Project Manager
- Data Review and Interpretation
- Queries
- Attention to Detail
- Qualified Trainer
- Analytical
- GxP Compliance
- Teamwork
- Communication
- Process Improvement
- KnowItAll
- OPUS
- SoftMax Pro SAP
- LabWare
- PharmSpec
- Phenix Events, CAPAs, CCRs
- GEODE Author, Reviewer, Approver
- ProCal
- Microsoft Office
Certification
- Drug Development
- SMS Practitioner
- Glass Fracture Analysis
- SEM Operator Training Carl Zeiss Microscopy
- Dale Carnegie
Timeline
Principal Scientist, Lead
Sanofi, Inc.
05.2023 - Current
Quality Control Manager
Sanofi Inc.
12.2016 - 05.2023
Quality Control Technician (various levels)
Sanofi Pasteur
11.2004 - 12.2016
Master of Science - Regulatory Affairs/Quality Assurance
Temple University
Master of Science - Plant Pathology
Clemson University
Bachelor of Science - Biology/Chemisty
University of Scranton
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