Manager Quality
Resume:
GEORGE GIANNARAS
***************@*******.***
Bethlehem, PA 18017
Summary of Qualifications
Over twenty years of laboratory experience in various technical fields including bio- medical, pharmaceutical and environmental testing.
● Expert in analytical instrumentation including HPLC, GC, GC/MS, FTIR, DSC Rheometry and Thermal Analysis techniques; Method Development, troubleshooting, calibration and validation.
● Proficient in writing and validating documentation; SOP’s, Batch Production Records, Work Instructions, Test Methods
● Process/Method Validation Protocols and Instrumentation Qualifications
● Compliance with cGLP and cGMP requirements
● Method Development for HPLC, GC, GC/MS, Quality Control testing and production materials
● Skilled at troubleshooting, laboratory investigations and problem resolution.
● Compliance with cGLP and cGMP requirements.
● Experience running various bio-assays including ELISA, RIBA and Western Blot
● Well versed in safety protocols and procedures; 24 Hour HAZMAT Technician training. Member of companies’ safety teams
● Ability to work with cross-functional teams
PROFESSIONAL EXPERIENCE
Dynalene Inc., Whitehall PA 2009-Present
Laboratory Services Manager/Analytical Service Chemist Managed analytical testing services laboratory. Responsibilities included pricing, scheduling, testing, report generation, payment, marketing and technical assistance.
● Managed day to day testing operations.
● Developed QC test methods for client.
● Identified and implemented testing for new and emerging markets.
● Generated website content for Lab Services webpage.
● Managed Google AdWords campaign.
Minrad Incorporated, Bethlehem PA 2009
Analytical Scientist
Developed and implemented new analytical GC test methods consistent with USP and ICH standards. Supported manufacturing in process optimization and troubleshooting.
● Developed and validated new GC test method for analysis of a contaminant in product.
● Performed cleaning validation of packaging process.
● Verified new USP GC method for use in QC laboratory. Orasure Technologies, Bethlehem, PA 2001-2008
Scientist II
Developed, investigated and evaluated processes and raw materials to produce the next generation of Oraquick Rapid HIV test, and to improve quality and extend shelf life of the current device.
Developed, investigated and evaluated processes and raw materials used in a lateral flow, oral fluid, Drugs of Abuse test.
● Established new process for concentrating Colloidal Gold that improved quality and reduced cost and time to produce.
● Established Batch Production Records, Work Instructions, SOP’s, Installation and Qualification Protocols, Quality Control Procedures for preparation of functionalized nanoparticles. Executed Validation of all processes, equipment and Quality Control tests related to the process.
● Implemented new design idea for next generation HIV Rapid Test device into working format by resolving formulation issues.
● Produced multiple new Colloidal Gold Conjugates for investigational use in next generation HIV Rapid Test device.
PSGA, Raritan, NJ 2001
Chemist, Raw Materials
● Analyzed raw materials used in solid and semi-solid pharmaceuticals and consumer goods utilizing USP Protocols for a large pharmaceutical manufacturer. Biocode, Inc., Bethlehem, PA 2000
Application Specialist/Quality Assurance
Investigated customer specific analytical methods for discrete markers in pharmaceuticals, fuels and consumer goods.
● Maintained Quality Assurance documentation and assured Quality practices were employed.
Aventis Pasteur, Swiftwater, PA 1999
Chemist, Method Development
Developed and validated methods for testing protein and carbohydrate vaccines. Analyzed samples for stability and release. Qualified instrumentation. Accupac, Inc., Mainland, PA 1997-1999
Quality Assurance Chemist
● Performed quality control analysis of raw and bulk materials, pharmaceuticals and consumer goods adhering to USP protocols or client provided methodology Geo-Centers, Inc., Edgewood, MD 1996-1997
Scientist II
Assisted in development process of a novel approach for capture and detection of target compounds in the atmosphere incorporating HPLC, GC and GC/MS/MS. All other information is classified as Secret by the U.S. Government.
● Oversaw two technicians working on sample capture aspect of the project. EA Laboratories, Sparks, MD 1992-1995
Group Leader/GC Chemist/Extraction Technician
Analyzed samples following EPA guidelines for pesticides, PCB’s and herbicides. Prepared samples following EPA guidelines for analysis of environmental contaminants by GC, GC/MS and HPLC.
● Supervised three GC chemists to ensure timely delivery of data.
● Represented the GC laboratory at management and production meetings.
● Generated reports, prepared standards, tracked samples, maintained instruments, maintained standards and instrument maintenance logbooks. EDUCATION
University of Delaware, Newark, DE
Bachelor of Arts: Biological Sciences
SPECIAL SKILLS/TRAINING
Ability to Use Minitab Statistical Software
Process Validation Principles and Protocols Training Basic Management Techniques Training
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