Ailime Díaz Pérez

***** ** **** **. 787-***-****

Sunrise, FL 33351 adb3ul@r.postjobfree.com

Summary:

Execute validation, method development, method transfer, and method verification protocols and reports.

Experienced working with API’s, solid dosage, oral solutions, medical devices, transdermal and biological products.

Around 15 years of experience in the regulated industry and quality units.

Use of instruments; HPLC, UPLC, GC, IC, UV/VIS, FT-IR, Elution/Dissolution Baths App I, II and III (HP Agilent, Varian/Vankel), Polarimeter, Karl Fisher (Volumetric Titration), pH Meter, TOC, Conductometer and SpeedVac evaporator.

Use acquisition data software like Empower II and III, Lims Labware, OpenLab, Chemstation, TotalChrom, Millenium and TiAmo.

Perform documentation and data review process, Investigations and Complaints.

Perform standards, reagents and solvents inventory and purchases.

Experience implementing and working with the 6S program for the laboratory and sample room area.

Experience with internal and external quality audits (FDA, TGA, PMDA, EMA)

Education/ Trainings / Certification:

July 2006 Interamerican University Bayamon, P.R.

B.S. Degree - Chemical Technology

July 2019

Florida Life Insurance License (2-14)

Experience:

AMRI, Albany, NY October 2018 – November 2019

QC Scientist / Team Leader - Lab Support Consultant

Perform API chemical testing; Assay, Purity, Related Substances and Moisture for release and stability samples under Stability Program and/or R&D

Review data and report methods for validation protocols.

Perform data and validation protocols review for stability test.

Use and maintenance of HPLC (Perkin Elmer and Waters)

Execute USP test method verification protocols, and standard qualifications.

Work with FDA found deficiencies

Responsible for team of four, coordinate with director and team supervisors to ensure

client satisfaction of team members.

Trainer of entry level scientists

Unipharma, Tamarac, Fl July 2018 – October 2018

QC Scientist

Write, Execute and report method transfer protocols for Otic, Oral and Eye solutions.

Write, Execute and report method verification protocols from USP monograph.

Write method validation protocols and method validation reports for Otic, Oral and Eye solutions.

Transcribe methods and protocols in the current format.

Perform data review for validation documents and stability test.

Use and maintenance of HPLC, TOC, Conductivity meter.

Cambrex, Charles City, IA October 2017 – May 2018

AD Senior Scientist / Consultant

Write method validation protocols and method validation reports.

Transcribe methods and protocols in the current format.

Perform data review for validation documents of other scientist.

Create documentation templates forms.

Use and maintenance of HPLC, GC and IC.

Performed and document development testing for new compounds.

Execute proof of concept testing, qualification and validation methods/protocols.

Patheon, St. Louis, MO Mar 2017 – Sept 2017

Senior Scientist / Consultant

Execute validation laboratory experiments, data interpretation and report obtained results

Execute content assay to rhASM

Contribute to progress report writing with supervision, communicating and daily communication with team members

Use and maintenance of HPLC, SpeedVac Vacuum Concentrator, and pH meter.

Ensures that assigned validation activities are performed timely and in line with the current requirements and cGMP

Execute validation protocols and prepared technical reports such as Pre Validation Studies, Performance Qualifications, and Requalification of biotechnology test systems to support the related registration documentation.

Provides review and approval of validation documents of other analysts.

Sancilio and Company, Riviera Beach, FL Feb 2016 – Mar 2017

Sr. Scientist – Analytical Services / R&D

Perform chemical testing; Assay, Dissolution, Purity, and Moisture for release and stability samples under Clinical Testing Program and/or R&D

Execute formulation protocols and developmental testing

Use and maintenance of HPLC, Dissolution Baths (App I, and II) and Karl Fisher.

Train and provide technical support to analysts as required.

Review of OpenLab Validation protocols executions.

Ordering and Purchases of reagents and laboratory consumables

Execute validation protocols for products in research and development stage.

Audit notebooks, logbooks, and validation reports to ensure precise documentation and compliance with departmental SOPs, FDA regulations, and product specification.

Review and execute protocols and reports for method validations, development, investigations and other technical projects.

Perform investigations for out-of-trend analyses, out-of-specification analyses designing and/or executing laboratory experiments, interpret data and contribute to progress, root cause and report writing

Perform departmental training for new analysts or other chemist to further the growth, understanding and industrial application of analytical Quality Control.

Noven Pharmaceuticals, Kendall, FL Nov 2014 – Feb 2016

Associate Scientist – QC

Perform chemical and physical testing for in process, finish product and stability transdermal products

Perform method validation for transdermal products to support of manufacturing improvement process

Use and maintenance of HPLC, UV and physical testing instrumentation.

Perform data processing and documentation of acquired testing results using Empower II and Lims Labware

Conducts QC lab investigations for out-of-trend analyses and out-of-specification analyses using Trackwise.

Performs trainings and provide technical support to analysts as required.

Perform qualitative and quantitative, chemical and physical testing on all products supported by manufacturing.

Actavis, Ft. Lauderdale, FL Jun 2011 – Oct 2014

QC Chemist II

Execute chemical testing for in process, release and stability samples like Assay, Dissolution, Content Uniformity, Purity, Id, and Moisture for solid dosage product

Use and maintenance of HPLC, Dissolution Baths, Karl Fisher and FTIR.

Execute validation protocols for new products.

Perform documentation and review process for acquired testing results.

Perform standards, reactives and solvents inventory and reorders.

Use acquisition data software like Empower and Lims.

Audit notebooks, logbooks, and validation reports to ensure precise documentation and compliance with departmental SOPs, FDA regulations, and product specification.

Participates in product transfers and launches.

Works with extended release, modified release and immediate release dosage products.

Perform qualitative and quantitative, chemical and physical testing on all products supported by manufacturing.

Perform departmental training for chemist to further the growth, understanding and industrial application of analytical Quality Control.

Pfizer, Vega Baja, P.R. Jul 2010 – Jun 2011

QC Chemist

Perform testing for raw materials products like Heavy Metals, IR, ROI, LOD and pH according of USP, EP or JP methods.

Perform Sieves and Balances inspection and calibration.

Perform reactive and solvents inventory.

Audit notebooks, logbooks, and validation reports to ensure precise documentation and compliance with departmental SOPs, FDA regulations, and product specification.

Perform a variety of chemical analyses and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product and stability samples in accordance with cGMP, GLP, DEA and company policies and procedures.

Boston Scientific, Dorado, P.R. Mar 2007 – Apr 2010

Laboratory Analyst II - QC

Use of equipment’s; HPLC, UV/VIS, FT-IR, Elution Baths, Polarimeter, Karl Fisher.

Perform Lot Acceptance, Chloroiridic Acid determination, Elution, Impurities, Identification, GPC, Residual Solvents, Residue of Ignition and Specific Rotation, Humidity, Acidity tests and NCO tests.

Perform pipettes calibrations and inventory control of reactive.

Perform test for test method transfer, stability samples and release samples.

Perform retention and discard process of retention samples.

Data review for lots release.

Technical knowledge of laboratory procedures and laboratory investigations process.

Experience in acquisition data programs such as Empower 2 software.

Implementation and maintenance of 6S program.

Review and execute protocols for method validations, development, investigations and other technical projects.

Watson Laboratories Caribe, Humacao, P.R. May 2002 – Feb 2005

Laboratory Analyst - QC

Use of laboratory equipment’s; HPLC, Karl Fisher Titrator, UV/VIS, FT-IR, Dissolution Baths, pH meter.

Perform Stability and Finish Product testing like Assay, Content Uniformity, Water percentage determination, dissolution, identification tests, chromatographic purity, TLC, extractions.

Complete documentation of analysis results. Complete training in capsules and tablets analysis.

Technical knowledge of laboratory methods and laboratory documentation handling.

Technical knowledge of laboratory methods, SOP’s, IOP’s changes or implementations.

Technical knowledge in laboratory investigations process.

Experience in acquisition data programs such as Millennium and training in Empower software.

Bristol Myers Squibb, Humacao, P.R. Jul – Sept 2002

Supervised Practice in the Industry / Environmental Laboratory

Perform environmental laboratory testing; Ash Analysis, Water Percentage, Viscosity Analysis, Density, pH to water samples.

Knowledge in related equipments; Viscometers, Density Meters, pH meter.

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