Quality Assurance Management

Daritzabel Laboy Santiago

HC#* Box **** t Yabucoa, P.R 00767

787-***-**** t ***********@*****.***

Analytical Chemist

A Recognized Expert in the Pharmaceutical and Chemical Industries

A high performing Analytical Chemist with 12+ years’ experience supporting method comparisons, method validations, method transfers, and method optimizations/improvement projects. Certified as a licensed chemist and in OSHA compliance. Exceptional ability to self-direct, participate in collaborative efforts, and lead and train teams. Technologies include Microsoft Suite, TrackWise®, Smart Lab, and Darwin Systems. Fluent in spoken and written Spanish and English.

CORE COMPETENCIES

Wet Chemistry t Spectroscopic and Chromatographic Techniques t Six Sigma Projects t SOP t Logbook Audits

Procedures & Analytical Investigations t Leadership and Team Collaboration t Training & Mentoring

Analytical Testing

ID, Assay, Related Substances, LOD, Residue, Water Content, pH, Optical Rotation.

Laboratory Equipment

FT Raman, FTIR, Dionex, HPLC, GC, GC Headspace, Karl Fischer, Automatic Titrator,

Conductimeter, Particle Size Analyzer, pH.

Risk Management and Federal Regulatory Guidelines

ICH Q8, ICH Q9, ICH Q10, GAMP V, ASTM E2500 t FDA, cGMP, cGLP

EXPERIENCES AND NOTABLE CONTRIBUTIONS

PHARMA BIOSERV INC, Dorado, PR 2005 – Current

Global regulatory compliance and validation company

Contractor for Lilly del Caribe, Inc. Guayama 2007 - Current

tReview analytical data and ensure compliance with current test methods, SOPSs, cGMPs, and protocol instructions

tCollaborate with technical services resulting in process improvement and cleaning validation

tSupervise and account for health and safety laboratory audits, employ streamlined operational methods with new employees to ensure laboratory efficiency and essential protocol compliance

tLead team member for Laboratory Method transfer, as well as execute and complete method validations

tPerform analytical investigations and change controls associated with quality control and quality assurance

Contractor for Glaxo Smith Kline, Cidra 2005- 2007

tAudited logbooks and essential laboratory documents, performed cleaning validation and certification tests

tImproved laboratory deficiencies by working under FDA remediation plan, trained new employees on data review

WATSON LABORATORY CARIBE, Humacao, PR 2003 – 2005

Pharmaceutical preparation companies industry

Quality Auditor 2004 - 2005

tSupervised raw material, finished product and batch manufacturing record compliance with current SOPs and federal regulations resulting in uninterrupted marketing release

tCollaborated with manufacturing, warehouse, QC material management resulting in timely and accurate shipments

Chemist II 2003 - 2004

tValidated products in line with established test plan and protocols in conjunction with technical services department

tPerformed analysis testing: ID, Assay, Related Substances, Loss on Drying, Residue, Water Content, TLC, Content Uniformity and Dissolution.

EDUCATION AND CERTIFICATIONS

Master of Science, Manufacturing Competitiveness & Major Pharmaceutical Products,

Polytechnic University of Puerto Rico, 2009

Bachelor of Natural Sciences, Industrial Chemistry, University of Puerto Rico, Humacao, 2002

Certified as Licensed Chemist (#4945) by the Government of Puerto Rico, Chemist Examination Board, 2003

Certified as Voluntary Compliance OSHA by the V.I.P Group and OSHA Camp Training Center, 2009

Certification in “Introduction to Industrial Biotechnology and Protein Analysis as Products of Biological Processes”, University of Puerto Rico, Humacao, 2014

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