Experience

Azzur Labs LLC

• United States
• Pharmaceuticals
• 1 - 100 Employee

• Microbiologist

  • Aug 2019 - Present

  Testing & analysis of environmental monitoring samples from clients. Enumeration and identification of bacterial and fungal isolates. Microbial media & chemical reagent preparation. Growth promotion and sterility testing of purchased, laboratory-made and client-provided media. Performing environmental monitoring of client manufacturing spaces & personnel. Data entry and generation of reports as well as direct client communications. Perform non-compliance investigations including deviations, laboratory investigations and observations related to laboratory testing efforts. Testing of water systems for total microbial presence, pH, total organic carbon & conductivity. Purchasing of laboratory materials & supplies. Show less



Baxter Healthcare Corporation

• United States
• 700 & Above Employee

• QA Laboratory Auditor

  • Oct 2018 - May 2019

  Responsible for closing investigations resulting from environmental monitoring OOT/OOS and product bioburden deviations. Assisted in closing special testing instances resulting from routine maintenance as well as non-critical & critical work requests. Counseled & re-trained microbiology technicians on SOP's, facility specifications, and cGLP/cGDP when responsible for environmental monitoring excursions. Reviewed laboratory data - environmental monitoring, product bioburden, microbial & chemical analysis of water systems, endotoxin testing, & microbial identifications. Show less



Ei SolutionWorks, LLC

• Landis, NC

• Senior Microbiologist

  • Oct 2017 - Sep 2018

  Microbial limit testing on finished product, bulk, raw material and stability samples. Antimicrobial effectiveness testing on stability samples. Antibiotic microbial assays for potency determination. Growth promotion and sterility testing of purchased and laboratory made media. Environmental monitoring of manufacturing spaces include compounding areas, packaging, raw material weighing as well as laboratory spaces. Testing of purified water systems for microbial presence, total organic carbon, conductivity and nitrates. Identification and enumeration of microorganisms. Assisted in non-conformance investigations including deviations, and OOT/OOS related to product results and environmental monitoring results. Show less



Glenmark Pharmaceuticals

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Microbiologist

  • May 2017 - Aug 2017

  Executed initial environmental qualification for areas of production - oral solid dose, sterile injectables, and aerosols. Performed bioburden testing on water systems (purified water, WFI, & pure steam), compressed air/gases, and personnel sampling. Identification and enumeration of bacterial and fungal species. Performed endotoxin testing (gel-clot method) and growth promotion of media. Maintained stock cultures for testing. Issued and revised GMP/GLP documents such as SOP's, protocols/reports, data sheets, etc. Show less



G&W Laboratories

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Microbiologist

  • Dec 2015 - Dec 2016

  Responsible for microbiological testing of raw materials, in-process, finished product, and stability samples. Responsible for environmental monitoring of air, water, surface & compressed air/gases. Executed special testing in support of method and process validation activities as well as investigations. Reported results generated during testing. Responsible for the maintenance of laboratory chemicals and supplies including organisms and growth media. Adhered to policies of EHS - Safety in the laboratory and proper handling of chemicals and lab waste. Show less



Hospira

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Laboratory Analyst

  • Mar 2014 - Jul 2015

  Microbiological testing for environmental and control studies in a regulated pharmaceutical facility. Data entry with LIMS software. Environmental monitoring, testing of bioburden, endotoxin, sterility testing, coliform, and biological indicators. Identification of bacterial and fungal species. Testing and sampling for water, raw materials, in-process samples, bulk drug substance, finished drug product and stability programs. Documented results of tests and analysis in accordance with cGMP regulations, trending data, coordinating sampling schedules and writing procedures. Show less



Bay Valley Foods

• United States
• Food and Beverage Manufacturing
• 400 - 500 Employee

• Quality Control Lab Technician

  • Mar 2011 - Apr 2013

  Performed quality testing of products, incoming materials and ingredients. Maintained records. Monitored HACCP compliance. Performed routine inspections and SOP audits. Performed physical and chemical testing during mixing, directing corrections to mix errors, ingredient substitutions and formula modifications. Inspected product packaging for correct fill, labeling, coding and integrity. Performed microbiological testing of finished products and raw materials as well as environmental monitoring. Data entry and weekly biostatistical analysis. Complied with GLP/GMP regulatory procedures as required by federal, state and employer protocols. Show less