Seeking a Position as an Analyst or Quality Control Technician
Overview
45
45
years of professional experience
Work History
Technical and QC Documentation Specialist
Millipore-Sigma
05.2024 - Current
I am working as a documentation specialist for a medical devices company. This involves writing technical documents and printing detailed labels that are being used to register the company’s medical products for overseas and domestic use. In this position, I am using Microsoft Teams, Office Suite, Spreadsheets, SAP, and other LIMS systems. Also coordinating with other members of the team using Microsoft teams in order to complete projects.
R&D and Quality Control Chemical Analyst
TJ/H2B
08.2016 - 11.2023
In this position I ran DGA samples using Headspace and Rack procedures. I was responsible for running the DGA Headspace using Varian Star program for the California site, as needed. I ensured that turnaround times were met and that the GC instruments were functioning properly. I performed the required maintenance on the instruments. I used analytical balances and pipettes to measure standards and samples.
Prepared Quality Control Samples and ensured that they passed ISO specifications. I also performed DBV, IFT, Acid and Power Factor testing on samples using BAUR instruments.
I analyzed samples for Oxidation Inhibitors using an IR system.
I determined the Viscosity and Corrosive Sulfur in various samples.
I generated particle data on samples using the BECKMAN coulter instrument.
I analyzed samples for moisture using the Karl Fischer Titration system.
I was responsible for preparing standards and sending them to various TJ/H2b sites as needed.
I worked on several projects in R&D such as determining Ostwald solubility coefficients, Gassing Tendencies, Stray Gassing, Microscopy preps, XRF, and Oxidation Stabilities.
All the analyses were performed under SOP, ISO, GMP, and Environmental Health and Safety Regulations (HSR)
QC Chemist and Team Lead
PACE/KIFF ANALYTICAL, ELAP and NELAP
04.2002 - 08.2016
In this position I have coordinated with staff to ensure all essential lab duties are performed accurately and under QC, ELAP, NELAP and TNI requirements. Tested drinking water and wastewater samples for inorganic and VOC analytes. I reviewed and generated reports to ensure high quality and accurate turnover of data. I was responsible for QC analysis performed on GCMS, GC, and IC instruments. I have tested drinking water samples for low level VOCs. Samples were also analyzed for organic and inorganic molecules in air and soil matrices. Extractions were performed on some water and soil samples. I have prepared mixes and QA standards used within the lab. I have provided training to technical staff. All the methods were under SOP and EPA guidelines and required strict QA regulations to be followed.
Pipettes, syringes, pH meters, and analytical balances were used during the analyses. I used the following computer applications in this position, i.e., Epic Pro, Agilent Chemstation, Chromeleon, Fox Pro databases, Chemstation Data analysis program, Microsoft Word and Excel. Extensive documentation, following protocols, attention to detail.
All the analyses were performed under SOP, EPA, and Environmental Health and Safety Regulations (HSR)
ASSEMBLER
ZEISS HUMPHREY SYSTEMS
06.2001 - 08.2001
ISO 2001 certified. Assembled lens analyzer equipment under GMP regulations for medical devices. I was responsible for building optical heads and housing units to completion according to demand. The Kanban system and Demand Flow Technology were used during this job.
CLINICAL LAB TECHNICIAN
ROTH, M.D., LLC
07.1997 - 07.1998
Performed urinalysis, throat cultures, microscopic examinations of tissues and bacterial morphology, gram staining of bacteria, and CBCs. Also glucose tolerance determinations were performed.
CHEMIST
SYNTEX PHARMACEUTICALS
01.1980 - 01.1996
Quantified cells, proteins, and biologically active compounds in human and animal tissues. Studied mode of action and structure activity relationships of proprietary compounds. Familiar with dosing regimens and surgery techniques used in pharmacology. I used a variety of analytical methods and equipment during my analyses such as: pipetting systems, organic solvent extractions, HPLC, RIA, ELISA, enzyme assays, microscopes, and Coulter Counters.
I performed microscopic examinations of blood and tissue specimens and used tissue culture techniques.
Responsible for quality assurance of clinical trial data used to complete IND filings. Prepared presentations, which highlighted essential information during the Project Team’s review of programs. Prepared method reports and other documents which summarized results and validated methods.
All analytical methods were performed under FDA, GLPs, GMPs, SOPs, and Environmental Health and Safety regulations (HSR).
Education
Bachelor of Science - Microbiology and Chemistry
CALIFORNIA STATE UNIVERSITY
SAN JOSE, CALIFORNIA
Skills
Editing and proofreading
API documentation
Adobe creative suite
Multimedia production
Content management
Web content development
Structured authoring
Software documentation
Usability testing
Document design
Version control
Teamwork
Teamwork and collaboration
Accomplishments
Proficient in QC and GCMS chromatography.
Proficient in Pharmacology
Proficient in preparing Quality Control Standards
Proficient in tissue and microorganism microscopy
Proficient in Data Management Systems
Proficient in Microsoft Office Suite
Received Research Recognition Award
SUMMARY OF QUALIFICATIONS:
Experienced in Quality Control documentation, analyzing results, and preparation of QC standards
I have fifteen years of experience in Biological Research which included small molecule drug research
Performed microscopy on animal and human tissues.
Used Antimicrobial agents during Research Projects.
One year of experience in Clinical Microbiology.
Skilled in the use of pH meters, analytical balances, and pipettes
I am skilled in using Microsoft Office Suite and Lab Information Management Systems (LIMS).
Received Research Recognition Award for outstanding achievement.
Eleven years experience in ISO certified manufacturing facilities.
Fourteen years of experience with FDA, GLP, GMP regulations in Pharma
Fourteen years of experience following EPA regulations in Environmental services.