Quality Control Assurance

Anthony P. LaVecchia

*** ** ***** ***, #*** Davie, Fl 33325 Phone: 786-***-****

Email: **********@*****.***

Objective To return to a management role in Quality Control/Assurance in

the pharmaceutical/biotech field.

Experience 2009-Present Health-Chem Diagnostics,

LLC.

Senior Scientist R&D

Develop, optimize/reformulate and troubleshoot the Health Check

Trans-Dermal Glucose monitoring system.

Troubleshoot and improve Cholesterol detection, protein and

glucose in urine, ovulation and pregnancy confirmation tests.

Troubleshoot various "point of care" diagnostic tests. ie;

Urinary Tract Infection detection (Nitrite in urine).

Develop, create, implement and/or revise departmental SOP's,

raw materials specifications, and batch records.

2008-2009 Goodwin Biotechnology

Inc.

Department of Regulatory Affairs, Quality Assurance and Quality

Control

Supervisor Analytical Quality Control

Supervised four QC analysts (QC analysts II, III, and wet

chemist).

Planned and oversaw daily and weekly assay and validation

schedules to coordinate with production schedules according to

cGMP.

Oversaw and coordinated the inspection, labeling and release of

bulk and final vialed product including label reconciliation

and final inspection paperwork

Supervised release of incoming raw materials, supplies and

equipment

Scheduled and supervised the executions of stability protocols,

ensuring the attainment of project timelines.

Reviewed and signed off on all analytical QC data.

Summarized data and wrote client reports.

Responsible for investigating/troubleshooting assay

non-conformances/problems.

Reviewed, wrote, and oversaw the execution of deviations and

investigations as necessary.

Wrote, reviewed and signed off on qualification and validation

protocols related to Analytical QC.

Provided input on assay improvements and data interpretation.

Reviewed and verified experimental data to statistically

summarize results and key findings.

Developed, created and revised departmental SOP's.

Planned and supervised qualification of new reagents for

various assays.

Ensured GMP compliance in the Analytical QC department.

Interface with Process Development, Manufacturing and Quality

Assurance departments to implement new client procedures and

process improvements.

Goodwin Biotechnology Inc

Department of Regulatory Affairs, Quality Assurance and Quality

Control

Quality Control Analyst II

Understood and performed a wide range of standard analytical

assays and techniques (ELISA, Western Blot, SDS-PAGE, IEF,

SEC-HPLC, IgM Methylation, Native PAGE, pH, HCP, insulin, and

OD).

Provided input on assay improvements and data interpretation.

Interpreted experimental data to statistically summarize

results and key findings.

Developed, created and revised departmental SOP's.

Released incoming raw materials, supplies and equipment.

Wrote and executed qualification and validation protocols

related to Analytical QC.

Responsible for qualifying new reagents for various assays.

Responsible for investigating/troubleshooting assay

non-conformances/problems.

Wrote and executed deviations and investigations as necessary.

Interface with Process Development, Manufacturing and Quality

Assurance departments to implement new client procedures and

process improvements.

1997-2007 Beckman Coulter, Inc.

Manufacturing Product Support (Retrovirology/Immunology)

Senior Scientist of Technical Operations

Responsibilities include developing experimental design,

writing, executing and reporting various protocols, frequently

conducting multiple studies simultaneously.

Responsible for evaluating reported problems/product failures

in Immunology and Retrovirology Reagent Quality Control

facility and implementing appropriate corrective actions.

Responsible for validation/optimization of new

components/reagents and cleaning/sampling protocols.

Responsible for evaluating reported problems in monoclonal

antibody purification/conjugation manufacturing facility and

implementing appropriate corrective actions.

Extensive experience optimizing, validating, and

troubleshooting the FDA licensed Coulter p24 Antigen ELISA

Assay.

Team Lead for the bioreactor/technology replacement project for

the In-Vitro Production. Responsible for evaluating potential

manufacturing processes for increased /optimized hybridoma

growth as well monoclonal antibody yield.

Participated in custom conjugations and purifications of

various monoclonal antibodies and flourochromes for outside

clients.

Interface with both Manufacturing and Research departments to

implement process improvements of various reagent components.

Responsible for qualification of new reagent vendors and

appropriate revisions of raw material specifications.

Participated in multiple FDA audits and interviews for IVD and

FDA Licensed products.

1993-1997 Coulter Corporation

Analytical Chemistry Department Cytometry/Immunology R&D

Research Associate

Design and perform assays on total and specific protein

quantitation and analysis with strong emphasis on development,

optimization, and validation of ELISA's, RIA's, and various

electrophoretic and diffusion gel assays including Western

Blot, PAGE, SDS-PAGE and IEF.

Experience in column chromatography (affinity and size

exclusion) purification as well as antibody/fluorochrome

conjugations.

Evaluate and interpret significance of experimental data

obtained.

Follow GMP as a part of routine laboratory practice in analysis

of pharmaceutical products.

Documentation experience includes authoring validation protocol

and standard lab SOP's.

Special acknowledgment received for work on the B1

pharmaceutical project

1992-1993 Coulter Corporation

Environmental Health and Safety Department

Chemical Safety Coordinator

Perform routine chemical and safety inspections.

Coordinate and conduct seminars on proper safety practices and

hazardous chemical handling for laboratory employees and author

of initial corporate Hurricane Preparedness Plan.

Interface with vendors to establish a corporate safety catalog

and instrumental in securing all MSDS's for corporate database

Education 1992 Florida International University Miami, FL

B.S. in Chemistry

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