ARTHUR KEVIN CARRASCO

**** ******** **, *******, ** 30024 678-***-****

Broad skill set, principally in the roles of Chemist and Laboratory Manager with several years of analytical experience in various industries, including pharmaceutical, thermoplastics, medical diagnostics and environmental testing. Effective in most applications of laboratory chemistry, from method development, method validation, and general analyses through data interpretation and general troubleshooting. Effective people skills, proficient at supervision of personnel, working directly with customers for complaint and problem resolution, lab management, product development, regulatory compliance, and attainment of various industry standard certifications.

WORK EXPERIENCE

VALENTINE ENTERPRISES INC., Lawrenceville, GA 01/2013 – 5/2016

A multimillion $ contract manufacturer of dietary supplements

Compliance Manager

Maintenance of regulatory compliance and licensing/certification: 21CFR 110 and 111, NOP, NSF, and Informed Choice

Attainment and maintenance of international compliance and licensing: Health Canada, and for dietary supplements for South Africa distribution

Creation and revision of SOP’s, and Protocol for IQ/OQ/PQ of testing and manufacturing equipment

Coordinator for HACCP, FSMA, and Food Defense programs

Establishment and maintenance of X-ray inspection program in accordance with Georgia Department of Health regulation

Responsible for Analytical Laboratory: method validation; protocol and execution, release testing; HPLC, UHPLC, ICP-OES, Protein by Automated Dumas

Development and management of Stability Program, in accordance with NSF guidance

ENCOMPASS PHARMACEUTICALS, Norcross, GA 01/2012 – 01/2013

A multimillion $ contract laboratory

Chemist – Product release Testing, Method Validation/Qualification/Verification/Transfer

GC analysis for Residual Solvents (USP <467>)

Finished product testing for various analytes by HPLC (products for treatment of animal parasites)

Creation, revision, and execution of method specific validation protocols

Preparation of Validation, Qualification, and Verification Reports

Management and execution of specific Method Transfers to third party testing facilities

Analyst training

SPEED LABORATORY, Buford, GA 11/2010 – 1/2012

A contract laboratory; principally operating in the Homeopathic market.

Director of Operations: Management of Facility, Analytical, and Microbiology Laboratories

Creation and revision of SOP’s as required to meet regulatory requirements

Method development, validation protocol, and validation execution (HPLC,GC, UV-Vis)

Product development (all natural hand/body cream base)

Daily office and laboratory staff scheduling

KIEL LABORATORIES, Gainesville, GA 2003 – 11/2010

A multimillion $ manufacturer of prescription medications.

Laboratory Manager 2005 – 11/2010

HPLC and UV-Vis method validation in accordance with USP and ICH guidelines

Resolution of analytical problems during method validation

DEA background cleared for handling of Scheduled substances

Preparation of Validation Reports

Management of Stability Program, and Method Transfers to third party testing facilities

Analyst training

Support of FDA audit/inspection/response activities

Arthur Kevin Carrasco Page Two

Supervisor of Release Testing 2004 – 2005

Supervision of Laboratory personnel for finished product testing in accordance with CFR/FDA requirements: HPLC (assay, dissolution, content uniformity), UV-Vis (assay), Disintegration

Resolution of analytical problems and OOS results during testing

Scheduling of finished product testing as required by marketing forecast and production schedule

QC representative for formal release of finished product (Release Committee)

Analyst training

R&D Chemist III 2003 – 2004

DOE and chemical analysis for investigation and Identification of Tannate impurity

Instrumental analysis for stability testing

Analyst training for R&D and QC

Method development and validation

POLYONE CORPORATION (Merger of M.A. Hanna & Geon Corp’s) 1995 – 2003

A billion $ global vendor and manufacturer of polymers, colorants, specialty formulations, vinyl, PVC and engineered resins for the thermoplastics industry.

POLYMER DIAGNOSTICS INC., (PDI), Suwanee, GA

A subsidiary of PolyOne Corporation.

Senior Chemist/Lab Manager

Development of analytical methods and standard color laboratory practices in accordance with ASTM, ISO 9000 and 17025, GLP, cGMP, and A2LA requirements

Contributed to the development of LASER mark and granite effect products that reached market

Made formulary recommendations to Product Engineers, production plants, and customers based on application, processing problems and analytical results

Managed laboratory personnel and daily operations

Analytical equipment maintenance and calibration

Equipment Specification: $450K in analytical equipment (HPLC, GC/MS, EDXRF, TGA, & DSC)

Co-directed activities in lab for achieving both ISO and A2LA accreditations

Routine analysis and assay of polymer and color-concentrates by HPLC, GC/MS, SPME GC/MS, Pyrolysis-GC/MS, GC-FID, UV-Vis, FT-IR Flame AA, EDXRF, Karl-Fischer Titrations, Muffle-Furnace (total inorganic content), TGA, & DSC

Senior Chemist, 1998 – 2001

M.A. Hanna Color, a subsidiary, U.S. leader in color additives for the plastics industry, with 18 plants in North America (responsibilities as above, without management of lab personnel and GMP/GLP accreditations)

Research Assistant, 1995 – 1998

Performed analyses in accordance with CFR and issued reports for FDA submission

Performed instrumental analysis of plastic samples

Supported product development with chemical analyses

Performed analyses for Quality Control

TECHNICAL CHEMICALS & PRODUCTS INC. (TCPI), Pompano Beach, FL 1993 – 1995

A $10M company developing, producing and marketing medical diagnostic urine test strips, and other specialty chemicals and products.

Lab Manager/Enzyme Analyst

Laboratory Management (three lab technicians)

Production Management (four production workers)

Supervised production processes, and maintained batch and QC records in accordance with GMP

Participated in establishing QA/QC requirements for R&D testing and product certification laboratory

Arthur Kevin Carrasco Page Three

Unique projects headed

Development of Haemocoagulase from Snake Venom (Pit Viper – bothrops jararaca) in accordance with USP-NF

Development of Multi-Function Urine Test Strips

WATER RESTORATION INC. (WRI), Davie, FL 1990 – 1993

A 10-person private laboratory – Environmental Consulting, Sampling, and Testing.

Environmental Chemist

Field sampling of ground water, waste water and soil

Site Assessment

Sample tracking and Chain of Custody

Chemical analysis of samples pursuant to EPA and ASTM methodology (EPA accredited laboratory)

Preparation of Analytical Report

QA/QC in accordance with EPA

Customer Service and Invoicing

ANALYTICAL INSTRUMENTATION AND TECHIQUES USED

GC-MS, SPME GC-MS, Pyrolysis-GC-MS, GC-FID, EDXRF, HPLC (PDA and RI detectors), UV-Vis, FT-IR, Flame AA, DSC, TGA, TMA, TGA/IR and various microscopic techniques.

Performance Characteristic Equipment: Dissolution Apparatus, Disintegration Apparatus, Friability Apparatus.

PHYSICAL TESTING APPARATUS USED

Capillary and Torque Rheometers, Melt Flow Indexer, Bulk Density,

Flex Modulus and Elongation, Coefficient of Friction, Weatherometers (Xenon and UV)

LANGUAGES

Speak Spanish fluently and French at intermediate to conversational level

ACCOMPLISHMENTS

Qualification as Internal ISO auditor, attainment of various agency certifications/licenses

EDUCATION

University of Florida, 1987 - Bachelor of Science

Majors: Chemistry & Microbiology

Broward Community College, 1982 - Associate of Science

Major - Chemistry

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