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Quality Assurance Lead Resume Example

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QUALITY ASSURANCE LEAD
Professional Overview
Highly talented Pharmaceutical chemist with a Master degree in Biotechnology, 3 years of quality assurance and regulatory affairs experience in the pharmaceutical field, academic researching experience in metagenomics, leadership, structured thinking, good interpersonal, organizational and communication skills.
Core Qualifications
  • Tissue culture, metagenomics, PCR, protein purification and microbiology.
  • Identified and evaluated new scientific methods, procedures, techniques, and instruments in pharmaceutical area.
  • GMP knowledge.
  • Characterization, identification and purification assays of active compounds.
  • Regulatory submissions, artworks, dossiers.
  • R&D.
  • Project managmement.
  • Multiple tasks achieving deadlines.
  • Knowledge in Databases (Oracle and MySQL) and Data Analysis.
  • Bilingual – Spanish/English.
Education
Master of Science:Biotechnology,Dec 2016Worcester State University － Worcester, MA, United States
Bachelor of Science:Pharmaceutical Chemistry,July 2009Universidad Nacional de Colombia － Bogota, Colombia
Fundamentals of Programming,2012Oracle University － Burlington Cambridge, MA, USA
Thesis/Dissertation
Graduate: "Alteration of microbiome by antibiotic contamination in Winogradsky columns using metagenomics".
Undergraduate: "antioxidant activity evaluation of secondary metabolites isolated from usnea roccellina motyka (parmeliacea) by reaction with DPPH free-radical and determination of its partition coefficient". 
Experience
Quality Assurance Lead, 07/2010 to 10/2011Pfizer S.A.S － Bogotá, Colombia
  • Coordinated and managed Pfizer animal health quality area.
  • Developed, established and reviewed artworks for labeling and packaging according to regulatory requirements.
  • Inspected, approved and released finished product and packaging material at Open Market Distribution Center (OMDC).
  • Prepared and implemented packaging material specifications and packing instructions to be followed at the distribution center.
  • Assured compliance of quality procedures to meet Pfizer quality standards.
  • Audited packaging and storage areas at the distribution center, and packaging material suppliers.
  • Implemented bar codes on primary and secondary packaging for animal health products.
  • Received Vision Awards 2011: Quality. Project: improvement of the technical documentation management for repackaging, stickering or labeling processes.
  • Achieved GMP License to operate at Open Market Distribution Center after successfully accomplishing INVIMA audit.
Manufacturing Section Lead, 10/2009 to 06/2010Marcel France － Bogotá, Colombia
  • Managed operations and supervised production lines, ensured good manufacturing practices (GMP) and personal protection.
  • Performed manufacturing planning according to raw materials, equipment, human resource and demand for finished product.
  • Reviewed and improved manufacturing process in dyes manufacturing area in order to ensure process efficiency and product quality.
  • Communicated proactively and worked collaborative with all the departments in the company: Engineers, Managers, Quality, Supply and Distribution.
  • Managed documentation under GMP and ISO14000 Standards.
  • Achieved ISO14000 company recertification.
Quality Assurance Analyst, 02/2009 to 10/2009Spai-Sons Pharmaceutical International Cosmetics － Bogotá, Colombia
  • Supervised and trained new workers, providing them instructions according to GMP and quality standards.
  • Implemented stability studies at Quality Control area for gels, lotions and creams.
  • Registered cosmetics products through FDA Voluntary cosmetic Registration Program (PRVC) and file creation SPL (Structured product Labeling for Drug establishment Registration and Drug Listing) for pharmaceuticals.
  • Elaborated, implemented and maintain SOPs.
  • Assisted the Technical Director by preparing and reviewing documents for regulatory submissions to INVIMA.
Quality Assurance Intern, 05/2008 to 11/2008Laboratorio de Cosméticos Vogue S.A － Bogotá, Colombia
  • Standardized and classified the color reference standards by preparing SOPs in the QC division to provide the dossier of each product to the Regulatory Affairs team.
Fellowships and Awards
Undergraduate: Awarded scholarship for achieving a high level of scholastic excellence. 
Pfizer Colombia- Received Vision Awards 2011:Quality.
Project: improvement of the technical documentation management for repackaging, stickering or labeling processes.
Presentations
Boston Bacterial Meeting, BBM
Poster Presentation: Antibiotic contamination of compost alters the microbiome in a Winogradsky column. June 14, 2016 (Harvard/MIT)
Memberships/Scholarly Societies
Regular Member in Beta Beta Beta Biological Honor Society by virtue of outstanding academic record.
Languages
English
Spanish
Skills
GMP, ISO, lead, manufacturing process, materials,  packaging, documentation, processes, Quality Assurance, Quality Control, Regulatory Affairs, researching, metagenomics, tissue culture, Bilingual, technical documentation, Data Analysis, Databases, Oracle Database, PL/SQL,
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Resume Overview

Companies Worked For:

  • Pfizer S.A.S
  • Marcel France
  • Spai-Sons Pharmaceutical International Cosmetics
  • Laboratorio de Cosméticos Vogue S.A

School Attended

  • Worcester State University
  • Universidad Nacional de Colombia
  • Oracle University

Job Titles Held:

  • Quality Assurance Lead
  • Manufacturing Section Lead
  • Quality Assurance Analyst
  • Quality Assurance Intern

Degrees

  • Master of Science : Biotechnology , Dec 2016
    Bachelor of Science : Pharmaceutical Chemistry , July 2009
    Fundamentals of Programming , 2012

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