Quality Control Assurance

A highly motivated, detail and goal oriented professional with proven quality control/quality assurance/regulatory/research appointments and experience. Supervisory skills coupled with the ability to manage multiple projects and

meet tight deadlines. Excellent technical abilities and a strong work ethic combined with excellent communication, organization, presentation and interpersonal skills.

Work Experience & Research

12/09 - Present

Project co-Manager Property Development

Design Aid, Cultural Resource Management & Sustainable Design

People Like Us: Public Benefit Corporation

Los Angeles, CA

• Assist to develop materials conservation strategies and methodologies for preservation consulting firm for public benefit and private real property development investments

• Project Management for Rehabilitation of Multi-Unit housing suffering significant benign neglect and absentee investors.

• Abatement of hazardous materials from historic structures via the least invasive methods to protect important

character defining features of historic significance.

• Participate in community advocacy to abate blight through public agency partnerships

• Provide framework for housing case management of at risk populations from seniors to other special needs housing types

• Participate in value design, engineering assessments and programing of real property development

12/01 – 03/09

Lab Manager/Instructor: Microbiology/Molecular Biology/Cell Biology

California State University Fullerton

Fullerton, CA

• Provide instructional support for students enrolled in courses in microbiology, cell biology, molecular biology, genetics, microbiology, physiology and biodiversity

• Managed all aspects of teaching labs including but not limited to maintaining stocks and working cultures of bacteria and preparing media and reagents as it pertains to the different teaching laboratories

• Managed Environmental Health and Safety policies for teaching labs

• Procurement of materials and supplies required for the proper functioning of over 10 different courses

• Supervise and train laboratory teaching assistants, graduate assistants and student assistants working in the laboratory and provide support for faculty and graduate student’s research

• Techniques employed in above classes/laboratories: Microbiology-bacterial isolation, aseptic technique, simple/gram stain, pure culture isolation, bacterial culture maintenance of over 200 different bacterial species, bacterial growth curve, biochemical identification test; Molecular/Cell Biology & Genetics- Genetics: classical Mendalian genetics using the fast plant, Brassica rapa, DNA Structure, Replication, and Manipulation: DNA annealing, plasmid DNA restriction digests, agarose gel electrophoresis, PCR and analysis of reactions, bacterial

transformation using TOPO® TA cloning kit, cloning of GFP gene into PCR2.1-TOPO, Gene Expression and Regulation using Arabidopsis thaliana; Population Genetics: Analysis of Alu Insertion Polymorphism

01/99 – 11/01

Quality Control Analyst/Supervisor

BioMarin Pharmaceutical, Inc.

Torrance, CA / Novato, CA

• Project team leader for set up of the Quality Control Analytical Lab that supported the development and launch of the first two commercial products, Aldurazyme® and Naglazyme

• Managed the daily operation of the analytical quality control lab including 8 QC analysts

• Daily scheduling of in-process and final product testing, including stability

• Training on existing and new SOP methods and instrumentation

• Performed chemical and biological tests on in process samples through final product CofA Testing

• Administration and coordination of the stability program for both alpha-L-Iduronidase (Aldurazyme ®) and arylsulfatase B (Naglazyme®) at BioMarin Pharmaceutical

• Liaison between QC and other areas in operations, quality assurance and product development regarding

analytical test results, resource requirements and analytical improvement projects

• Audit, review and approve in-process testing and data, release testing data and stability protocol data of clinical product

• Assess the impact of procedural deviations and investigate Out of Specification (OOS) lab incidents/results including making recommendations/implementations or corrective/preventative actions

• Assay and method development for QC analytical assays required for in-process and release testing per FDA and ICH guidelines

• Assay validation (IQ/OQ/PQ) on QC processes and assays

• Manufacture of GM1391 working cell bank used in biological uptake assays

05/97 – 01/99

Staff Research Associate IV

LA BioMed (BioMarin joint venture)

Iduronidase Production Laboratory (IPL)

Torrance, CA

Manufacturing Associate

• A team leader in the manufacturing (thaw to final product) of the human, recombinant protein, alpha-L- Iduronidase – small/large scale mammalian cell culture and small scale purification

• Operation and maintenance of pilot plant (3L, 5L, 25L, 40L) and small scale (110L) bioreactors including troubleshooting of pH meters, DO probes and CO2 analyzers

• Small Scale Purification: heparin, phenyl and sizing columns and UFDF operations for harvest and final drug substance

• Involved in design of viral inactivation/viral filtration steps

• General Production Activities: excellent aseptic technique used in cell banking and cell culture for production, media and buffer preparation, operation and maintenance of various clean room equipment, electronic tracking of raw materials used the manufacturing process

• Experience in sterile fill finish

• Involved in design, build out, commissioning and start-up of GMP facility

Quality Control Associate

• Designed and established the quality department: QA, QC Analytical and QC Microbiology

• Performed chemical, biological and biochemical tests on intermediates through final product CofA testing

• Performed chemical and/or biological tests of incoming raw materials used in manufacturing and analytical processes according but not limited to USP/BP/NF methods

• Environmental monitoring sampling and testing of facilities and utilities under CGMP guidelines

• Established an in-house stability protocol for alpha-L-Iduronidase

• Final Bulk Product Validation on manufacturing processes and QC assays

• Writing, editing, and reviewing Standard Operating Procedures (SOPs), Stability Protocols and Validation Protocols

• Review of in process Batch Records and product release data

• Establishment and maintenance of the QA document control tracking system

09/96 - 05/97

Production Biologist I

Focus Diagnostics (formerly Focus/MRL)

Diagnostic Division

Cypress, CA

• Daily maintenance and harvesting of antigen specific suspension and adherent cell lines under GLP conditions;

• Mycoplasma testing of all cell lines

• USA and International production of antigen specific diagnostic kits (FDA-cleared kits to analyte specific reagents) used to diagnose, treat and manage infectious disease

• GLP record keeping, maintenance and calibration of cell culture equipment

• Set up inventory control system to track incoming and outgoing cell culture reagents, virus strains, cells, etc.

11/95 - 09/96

Research Associate II (laboratory of Diane Prager, M.D.)

Department of Endocrinology

Cedars-Sinai Medical Center

Los Angeles, CA

• Provided custom oligonucleotides and purification to Davis Research Facility comprised of more than 200 principal investigators. Purification done by oligo purification cartridges, spin columns, SDS-PAGE, reverse-phase

chromatography (C18) and Sephadex G-50 columns

• Cell culture and passage of breast cancer tumor cell lines MCF7 and MDA231 used in cloning Transfection with a mutant and wild type Insulin Growth Factor-I receptor (IGF-IR) Binding assays performed on transfectants using 125I-IGF-I to select clones with the best uptake

11/92 - 11/95

Staff Research Associate I (laboratory of Charles Glabe, Ph.D.)

Department of Molecular Biology and Biochemistry (MB&B)

University of California, Irvine

• Lipid specificity of the sea urchin protein, bindin, using spectroscopy, fluorometry, aggregation assays and standard biochemistry techniques; enzyme kinetics and liposome production

• Binding assays of sperm and egg to determine interspecific fertilization relationships and the egg agglutinating activities of recombinant chimeric bindins

• Lab techniques utilized: agarose and polyacrylamide gel electrophoresis, western blot, auto radiography, protein iodination, DNA miniprep and analysis, automated DNA sequencing, transfection, transformation in E. coli bacteria, plasmid propagations and restriction enzyme digest and analysis

• MB&B’s “Core Lab” Team Member –provided custom oligonucleotides, DNA Sequencing and custom peptide synthesis (manual and automated) for more than 500 professors in more than 35 departments in 3 different schools within University of California Irvine

Training Courses and Professional Associations

• Introduction to cGMPs for Laboratories

• Validation and Certification of the Quality Control Laboratory

• GMP Compliance – Meeting the U.S. and International Regulatory Expectations

• Parenteral Drug Association (PDA) and American Society for Quality (ASQ) member

Education

B.S. Biology, University of California, Irvine

References Available upon request

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