Summary
Overview
Work History
Education
Skills
Certification
Educational Accomplishments
Languages
Timeline
Generic

Juan José Novoa

Summary

Experienced Quality Control Analyst with demonstrated track record of improving products and procedures through the use of SOP's and proper GDP practices by leveraging hands-on inspections, testing methods and data analysis. Disciplined professional with systematic approach to fulfill valuable end product. Applies excellent attention to detail and critical reasoning to successfully conduct experiments.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Quality Control Analyst

Lonza Biologics
05.2021 - Current

Training

  • Trained and coached existing and new employees on multiple critical biological and endotoxin assays under cGMP regulation; assays such as Medical endotoxin, medical device bioburden, bioburden membrane filtration of product amongst many other biological assays

Laboratory Testing

  • Medical endotoxin testing with the use of instruments such as LAL ( Limulus Amebocyte Lysate) readers. The use of this test is to analyze the gram negative bacteria that is present in medical devices, injectable pharmaceuticals and preliminary pharmaceutical product for future medicine.
  • Endotoxin gel clot assay. Also a form of endotoxin testing to make clotting possible in performing medical performances such as surgery amongst others.
  • Bioburden membrane filtration assay of raw materials needed for production, preliminary biologic product for pharmaceutical medicine, and testing of water needed to for all testing of product and raw material.
  • Spread plate biological assay. This assay is mainly used to test raw materials that are needed in the production of product to be made.
  • Pour plate biological assay used to identify actual bacterial growth on media used and compare it to the specification that is needed to properly use all media for assays being performed in the laboratory.
  • Appearance testing. Samples that require visual testing, pH testing, and bead appearance is what is done in this assay. All this to insure different parameters are met per SOP.
  • Inspected raw materials ready for testing and compared against standards to meet regulatory requirements and specifications.

In office tasks

  • Performed change control of the Limulus amebocyte lysate readers to new location.
  • Perform periodic review of all SOP and documentation that is used in the lab and office.
  • Documentation review per GDP practices to align with USP (United States Pharmacopeia )
  • Reviewing all assay documents that have been tested in the lab of fellow co-workers before submission to Quality Assurance.


Quality Control Chemist

Anaspec Inc.
01.2021 - 04.2021

In the Laboratory

  • Prepared and standardized test equipment, test solutions and reagents to enable successful testing completion.
  • Operated specialized scientific equipment and performed complex procedures to execute high-level analytical testing tasks such as Liquid Chromatography Mass Spectroscopy.
  • Carefully handled lab samples and disposed of waste by adhering to safety protocols.
  • Advised chemists and laboratory technicians on existing and emerging quality control methods to enhance testing and research capabilities.

In the office

  • The responsibility of creating Certificate of Analysis (C of A) for samples that were new and to be tested
  • Receiving materials/chemicals and making sure they are in compliance with the C of A of each material that will be used

Volunteer

Kaiser Permanente
07.2019 - 08.2020
  • Welcoming patients to the facility and giving them the best welcome possible.
  • Responsible for discharging patients to their cars after their surgery/stay at our hospital
  • Used strong interpersonal communication skills to convey information to out patients
  • Communicated with staff members to stay informed about volunteer opportunities and events.

Peptide Chemist/Laboratory technician

Anaspec Inc.
06.2019 - 08.2020

In the Laboratory

  • Maintained organized, safe and efficient laboratory environment to minimize accidents and prevent cross contamination.
  • Performed technical laboratory functions in compliance with regulatory agencies and safety requirements.
  • Through the use of a symphony machine, peptides were coupled to make the desired peptide chain.
  • Instrumentation such as roto evaporation was used for evaporation of the coupled sample and then transferred to the purification department.
  • Manual coupling of hydrophobic amino acids is performed for correct coupling of the chain.
  • Preparation of chemicals (HCTU, Buffer B, Tri-Fluoro acidic acid buffer) were prepared to facilitate the coupling of amino acids.


Research Assistant

San Francisco State University
09.2016 - 05.2018
  • Worked both independently and collaboratively in fast-paced laboratory environment.
  • Performed statistical, qualitative, and quantitative analysis on research samples.
  • The use of the NMR machine was used to perform experiments on research given by the chemistry department.
  • Roto evaporation was also conducted to purify the samples


Education

Bachelor of Science - Biology, Physiology

San Francisco State University
01.2018

Skills

  • Sampling Procedures
  • Corrective Actions
  • Testing Procedures
  • Medical Endotoxin Chromogenic, Mass spectrometry, LC-MS, and HPLC chromatography Analysis

Certification

BLS CPR certified, American Heart Association

Educational Accomplishments

Biggest accomplishment of all was to be the first of my family to graduate college with a B.S having come here illegally to a new country as an illegal immigrant.

Languages

Spanish
Native or Bilingual

Timeline

Quality Control Analyst

Lonza Biologics
05.2021 - Current

Quality Control Chemist

Anaspec Inc.
01.2021 - 04.2021

Volunteer

Kaiser Permanente
07.2019 - 08.2020

Peptide Chemist/Laboratory technician

Anaspec Inc.
06.2019 - 08.2020

Research Assistant

San Francisco State University
09.2016 - 05.2018

Bachelor of Science - Biology, Physiology

San Francisco State University
Juan José Novoa