Betty Hiraldo

EDUCATION

University of Florida

Masters of Science in Microbiology & Cell Science; Major: Virology, Expected 2021

Florida State University

Bachelors of Science

Major: Exercise Physiology; Environmental Studies Minor: Chemistry, December 2014

EXPERIENCE

March 2019-Current

Pfizer

Microbial Investigator

•Investigate complex bio burden and environmental monitoring excursions for lot related products (i.e., intravenous medicines and medical devices) with use of Six Sigma philosophy

•Conduct visual inspections and GEMBA walks throughout production.

•Gather data in LIMS to assess to host meetings amongst staff to decipher most probable root causes for the sources and/or possible vector means of recovered microbial isolates for throughout aseptic filling or environmental excursions.

•Identify discrepancies or impacts to implement CAPA’s.

•Assess and prepare necessary data for presentations to excecute/approve CAPA’s.

•Determine scope, product impact, root cause and corrective actions for deviations from established procedures by interviewing, sampling, and applying the use of quality tools and techniques with realistic timelines for completion.

•SOP revisions

•Write up final report for lot related excursions i.e., personnel monitoring out of actions, environmental monitoring; viable or non-viable samples (particulate), bioburden and water out of actions.

Baxter Health Care July 2018-March 2019

Microbial Investigator

•Investigate quality events and determine if potential product impact exists and determine root cause

•Investigate Microbial Out of Limits (Problem solving and research)

•Investigation and writing of deviation reports related to Aseptic manufacturing

•Evaluate Laboratory Methods and excursion input (SOP utilized, analyst, media, growth promotion)

•Determine scope, product impact, root cause and corrective actions for deviations from established procedures by interviewing, sampling, and applying the use of quality tools and techniques with realistic timelines for completion.

•Evaluate or ameliorating quality plan (CAPA’s or NCR’s)

•Participate in cross-functional teams to identify effective corrective and preventive actions to improve process quality.

•Responsible for communicating project updates to management team, internal colleagues and external collaborators

•Conduct internal audits of processes, systems and procedures

•Apply expertise in laboratory disciplines to perform technically sound laboratory investigations in a timely manner to meet business and compliance needs

•Implementing preventative measures to eliminate microbial OOL’s

•Editing SOP’s and microbial limit parameters

•Maintain training and hands on skills to remain familiar with the QC assays by assisting in lab, participating in training and qualification activities as directed by his/her management,

Aerobiology Associates August 2017 – Dec 2017

Microbiologist

rd

•3 party testing for GMP, healthcare and commercial clients

•Environmental Monitoring for Hospitals including Bioburden of surgical tables

•GMP Pharmaceutical Clean Rooms and equip Environmental Monitoring testing

•Spore traps- environmental air samples collecting fungal spores on gel i.e,, cladosporium, ascospores, basidiospores, hyphae fragments, stachybotrys

•Direct exam- tape samples of fungi surface analysis

•Water testing for hospital, cruise lines

•Testing legionella utilizing BCYA agar

•Frequent proficiency testing: bi-monthly proficiency exams for spore traps, direct exam, legionella recognition

•Perform microbiology testing for clients including GMP and environmental samples

Actavis Pharmaceuticals October 2015 – June 2017

Microbiologist

•USP & EP method, aseptic technique water sampling for Site from various loops & municipal samples

•Water testing via membrane filtration, testing for microbial content and coliforms

•Microbial limits testing for different samples using aseptic techniques adhering to validated methods, equivalency reports.

•Media Culture prep inoculating selective agars to test growth promotion and inhibitory properties

•Identify colonial morphology then Gram stain bacteria and mold to identify colonies assuring none are life threatening objectionable pathogenic organisms, while in compliance with standard operation procedure, use KOH testing for variable gram positive or gram negative organisms, Oxidase testing, Possible re-streaking to obtain fresh culture

•Perform Environmental sampling/testing, Ambient air and Compressed air testing

•Assist Supervisor in preparing lab metrics for general lab use and audits: composing trending reports

•Support leadership in managing/prioritizing incoming commercial samples and releasing samples within allotted time.

•Review all samples to assure samples were tested within validated parameters and meet specification

•Assist in Developing test methods and review calculations to ensure accuracy in master formulation

•Collaborate with QA to develop equivalency reports when samples are made of same composition

•Support in lab process innovation to increase overall efficiency and turnaround time of incoming samples

•Follow laboratory SOP and GMP adhering to FDA protocol

Beckman Coulter March 2015 – June 2015

Senior Reagent Scientist

•Test raw materials in cGMP environment, to determine an absolute cell count and CV levels in FC500 flow cytometer instrument

•HPLC to confirm compounds identification and purity. Sample injected and carried onto detector with carrier on for separation; based on polarity or solubility.

•Prepared Buffers and standard solutions

•Synthesized polymers for bead generation to make Flow count fluorophores, Sieving 10 micron beads, Flow cytometer testing on beads sizes along with making bottling

•Flow assays for to check CV levels.

•Writes/reviews SOPs for laboratory instrument use and calibration

•Used cell sizer to test raw material and measure cell size; calibrated machines daily; Cytometers, pH meters, cell sizer

•Prioritize and solve other secondary assignments and trouble-shoot machines

•Dissolution of expired chemicals and reagents

•Performed CalMan instrument calibration

Florida State University November 2011 – December 2013

Lab Assistant

Improved overall lab efficiency by 45% for students and TA’s by organizing reagents based on their chemical properties and

needed amounts for lab use such as Diethyl Ether, Hydrochloric acid, Formaldehyde

•Experience preparing clear and concise reports, policies, procedures, correspondences and other written materials

•Helped students achieve accurate reading on their products analysis for reports through use of Infrared Spectroscopy, melting point machine, NMR & H-NMR readings to determine Chemical shifts

•Gel Electrophoresis use to analyze DNA; assisted students in the better understanding the use of measuring the DNA strands and stain them for visibility.

•DNA sequencing reactions, plasmid purification

•Recombinant protein binding

•Utilized PCR to amplify DNA strand in lab, taught students to utilize Polymerase to bind to begin DNA copies along with final steps utilizing Taq Polymerase to measure viral loads in lab

PCR copies specific segment of students unknown bacteria, then was subsequently identified

•TLC, thin layer chromatography for compound analysis, HPLC analysis and Assisted helping student set up chromatography apparatus and figure out which compound was present

•Biology lab, cell extraction, placed cells in appropriate pH levels for separation

•Example of the HPLC experience is measuring the amount of Tetracyclines, an anti-biotic, in commercial milk

•Used EDTA buffer for extraction

•It was also added to the buffer to prevent interference

•Followed by deproteinizing the milk matrix with acid then solid phase extraction with C18 or a polymeric sorbent, used C18. Afterwards evaporated the solvent before HPLC analysis

•Centrifuged and add buffer to the milk, decant the supernatant, wash off the residual sugars, vacuum then test each sample

•Recorded the peaks and retention times, calculate the concentrations

Florida State University August 2013- December 2013

Metabolic Trials Intern

•Participated in pharmocokinetic studies

•Collected patient information, vitals and physical factors

•Analyzed dissemination and excretion of drug

•Initiated and closed out patient reports, also data reviewer

•Organized and participated in Study Initiation Visits (SIV) in collaboration with the Study Team

•Evaluated absorption rate and bioavailability in each phase

•Examined pharmacodynamics interaction

•Expertise Bio-analytical methods using HPLC and Validation of HPLC

•Reviewed protocol

•Collected patient data

•Reviewing the statistical output to evaluate study results

•Experience with GCP, GLP and ICH guidelines and other guidelines applicable to conduct BE studies/ clinical studies

SKILLS

•Microsoft products i.e. Excel, Word, PowerPoint, LIMS software

•(ADCC, CDC, MOA [Neutralization, Antagonism/Signaling) and bioanalytical assays (ELISA, ECL) flow

•cytometry, tissue culture, transfection, labeling of reagents (Biotinylation, FITC-ylation), SDS-PAGE, Western,

•protein expression and purification

•Use of DNA and plasma purification kits and Taqman probes for qPCR

•Dean’s List 2009 Women of Tomorrow Academic Scholarship

•Dean’s List 2010 FSU Merit Scholarship

•Dean’s List 2010

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