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Theodora Miller Email Address


Job Title

Senior Manager Quality Assurance Validation- Cell and Gene Therapy Catalent Pharma Solutions BioPark


| Pharmaceutics International, Inc


Strategic thinker ●.Excellent communicator ● Creative negotiator ● Logical problem solver Implementation ● Integration ● Global Materials Management ● Quality Assurance Passion for technology with ability to develop and implement new business opportunities Leadership skills with keen vision, economic sensitivity and analytical skills. An innovative Quality Engineer with a strong career of domestic and international work experience in progressively more responsible positions with a variety of industries with large capital equipment, combining vision, technical prowess and business-management expertise. Background and work experience range from process/project chemical engineering in R&D and analytical labs, and manufacturing facilities (Biotechnology, Pharmaceutical, Medical Devices, Department of Defense and Aerospace industry, Automotive, Printing, and Polymers industry) with areas of focus on: •New Product Development and Transfer Technology •Product sustaining and yield enhancement •Foundry business and process technical support •Project Management •Quality, reliability and failure analysis (RCA- Root Cause Analysis) •Product and Process Validation •Equipment Installation, Operation and Performance Qualification. Enforce work standards, write standard operation procedures, work instructions, train personnel, review and resolve work discrepancies to ensure compliance with contract requirements, domestic and international regulatory legislation (FDA/EU, cGMP, OSHA, ISO 9000). Execute operational excellence initiatives and specific computer applications as: •DMAIC (Define, Measure, Analyze, Implement and Control) •6 Sigma (5S +1) (Champion Certificate holder) •Statistical data analysis (DOE) (Design of Experiments) •Microsoft Office (Word, Excel, Power Point, Project, Access) •Visio, JMP, DOORS, ORACLE, AGILE, SAP, ApplicationXtender, EMARS, VEEVA.

Last University
Attended Faculty of Industrial Chemistry Polytechnic Institute
Lives in Lutherville Timonium.

Other people working at Pii:

Andrey PavlovSenior Product Specialist Informatics
Bibha DebManager Administration and Operations
Jay ShuklaAssociate Director, Aseptic Quality Assurance
Ken LavinQuality Assurance
Mark TrainorSenior Manager Global Supply Chain Planning Business Partner, SAP Enteprise Program
Mark Di IorioQuality Assurance, Director of Process Quality
Alyson KellyParalegal
N. Stephen********@pharm-int.com
Sheryl BasileExecutive Director Human Resources
Syed AbidiPresident and Chief Executive Officer
Mohammed ShekhaniVice President of Quality
Kurt Nielsen PhdPresident and Chief Executive Officer
Barbara RenzeScientific Writer
Sajid PervezDirector Information Technology, Pharmaceutics International, Inc
K. Brennfleck**********@pharm-int.com
B. Sasaki*******@pharm-int.com
A. Ahmed******@pharm-int.com
Mohammad HamedooniQuality Assurance Inspector
D. Quarles********@pharm-int.com
T. Ng***@pharm-int.com
C. Strauss********@pharm-int.com
S. Beckmann*********@pharm-int.com
A. Borodin********@pharm-int.com
Toni ValeTraining Manager

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