Sharon Pabon Santiago
Guayama,Puerto Rico
Summary
Dedicated Quality Control Analyst with over 20 years of experience in regulated pharmaceutical environments. Proven expertise in quality operations laboratory, encompassing raw materials, validation, method transfer, in-process, cleaning, stability, and finished product testing. Proficient in cGMP practices, corporate policies/guidelines, and international pharmacopoeias (USP/NF, EP, JP). Adept in analytical techniques and instrumentation. Strong analytical and problem-solving skills, coupled with proficiency in data analysis and interpretation. Highly organized and detail-oriented, with a proven ability to prioritize tasks and meet deadlines. Committed to ensuring product quality and compliance.
Overview
21
21
years of professional experience
Work History
LABORATORY ANALYST
MERCK LPO
LAS PIEDRAS, PR
06.2016 - 12.2024
- Receives samples and performs in the specified time limits chemical and physical testing of Raw Materials, Stability, Process Validation, Method Transfer and Finished Goods, as required, in accordance with internal procedures or compendia requirements.
- Executed analytical testing as described on procedures and protocols, as required.
- Documented and interpreted results, in a clear, concise, and accurate manner with a scientific perspective.
- Detected and reported any analytical failure and/or out of trend results to the area Supervisor in a timely, clear, and concise manner.
- Kept the Supervisor informed regarding progress of testing, due dates, delays, and other situations.
- Verified analytical data generated from all laboratory areas, as required.
- Operated and calibrated laboratory equipment, as required.
- Provided technical support to other areas regarding laboratory issues, such as new methodology, regulations, and instrument troubleshooting.
- Operated and performed initial troubleshooting to analytical instruments.
- Followed and enforced all safety procedures.
- Revised procedures and recommended necessary changes to the area Supervisor.
- (ACT-1) 2016-2018
ASSOCIATE QUALITY CONTROL
AMGEN MANUFACTURING LIMITED
JUNCOS, PR
07.2014 - 06.2016
- Performed analytical testing of drug product and stability samples; characterization, method development, sample and data management, laboratory investigations and non-conformances, cleaning validation recovery studies, and supporting analytical method transfers, validations and protocols.
- Verify data of testing on logbooks and LIMS to release lots.
- In charge of receiving reference standards and samples.
- Participate in the document revision process of analytical methods and SOP’s.
- Perform chemical assay, impurities and content uniformity tests by HPLC Reversed Phase Chromatography.
- (KELLY SERVICES)
SCIENTIST I
JANSSEN ORTHO, LLC
GURABO, PR
03.2012 - 03.2014
- Chemical and physical testing of raw materials and finished products (solid dosage) such as: Assay/ID, Purity, CU/WV, Dissolution, Moisture, IR, and TLC.
- Review data of solutions and standards of released lots.
- Work on Laboratory Investigations, Protocols and Process Validations.
- Work with Controlled Substances.
- (KELLY SERVICES)
LABORATORY ANALYST II / ADMINISTRATIVE
CHEVRON PHILLIPS
GUAYAMA, PR
11.2009 - 01.2012
- Performed chemical analysis of wastewater influent and effluent, sludge and industrial wastes and including biochemical, and bacteriological tests.
- Runs tests to determine amounts and degrees of pH, alkalinity, volatile acids, total solids, density, dissolved oxygen, organic material content, coliform bacteria, residual chlorine and heavy metals.
- Performs organic loading tests of TOC, chemical oxygen demand (COD), ammonia as N, total phosphorous and total suspended solids (TSS).
- Perform laboratory inventories of gases, reagents and materials and coordinate and verifying the hazardous waste materials disposal and all calibrations and maintenance of the instruments are performed within scheduled.
- Laboratory set up and the implementation of new tests and procedures.
- (CH2MHILL PUERTO RICO, INC.)
LABORATORY ANALYST
CHEVRON PHILLIPS CHEMICAL PUERTO RICO CORE, LLC
GUAYAMA, PR
02.2004 - 10.2009
- Hydrocarbon liquid samples testing from units, tanks, ships and incoming naphtha, mixed-xylenes, gasoline and diesel into chromatograph.
- Collection and analysis of environmental samples according to ASTM procedures and EPA methods.
- Worked on the NPDES monthly report and the regulatory EPA Discharge Monitoring Report (DMR) QA Performance Studies.
- Support and compliance on EHS audits and regulatory trainings.
- OSHA40 hours in General Industry Safety and Health Course Certification.
Education
BACHELOR DEGREE IN SCIENCES - Chemical Technology
INTERAMERICAN UNIVERSITY OF PUERTO RICO
GUAYAMA, PR06-2004
Skills
- Analyst / Reviewer
- Empower 3, ELN, LIMS, Smart Lab (LMES), CIMS, ATP
- UPLC and HPLC - Waters/Agilent
- HPLC, GC, UV-VIS, FTIR, AA, ICP, Dissolution, Karl Fisher, Analytical Balances, pH Meters, Viscometer, Specific Gravity Apparatus, TOC, Volumetric, TLC and other laboratory instruments
Languages
Spanish
First Language
English
Upper Intermediate
B2
Timeline
LABORATORY ANALYST
MERCK LPO
06.2016 - 12.2024
ASSOCIATE QUALITY CONTROL
AMGEN MANUFACTURING LIMITED
07.2014 - 06.2016
SCIENTIST I
JANSSEN ORTHO, LLC
03.2012 - 03.2014
LABORATORY ANALYST II / ADMINISTRATIVE
CHEVRON PHILLIPS
11.2009 - 01.2012
LABORATORY ANALYST
CHEVRON PHILLIPS CHEMICAL PUERTO RICO CORE, LLC
02.2004 - 10.2009
BACHELOR DEGREE IN SCIENCES - Chemical Technology
INTERAMERICAN UNIVERSITY OF PUERTO RICO