Experience

BioScreen Testing Services

• United States
• Biotechnology Research
• 1 - 100 Employee

• QA Analyst III

  • Oct 2017 - Present

  • Perform technical and compliance review of chemistry and microbiology test data and approve result reports in quick turn-around time. • Conduct thorough investigations associated with OOS, CAPA or deviation within a tight timeline. • Technical review and approve methods, validation protocols and other quality documents to ensure accuracy and compliance. • Provide technical assistance to colleagues in data review and non-conforming test result investigations. • Perform technical and compliance review of chemistry and microbiology test data and approve result reports in quick turn-around time. • Conduct thorough investigations associated with OOS, CAPA or deviation within a tight timeline. • Technical review and approve methods, validation protocols and other quality documents to ensure accuracy and compliance. • Provide technical assistance to colleagues in data review and non-conforming test result investigations.



Avid Bioservices

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Senior QC Analyst

  • Jun 2015 - Oct 2017

  • Performed testing through different stages of completion of biological drugs in conjunction with assisting in method transfer and validation projects to meet clients’ tight deadlines. • Technical applications such as HPLC, SEC, ELISA, SDS-PAGE, IEF, and enzyme potency • Reviewed laboratory notebooks, raw data and testing results to ensure accuracy, compliance and completeness prior to QA submission. • Provided technical support in Deviation/IR/ DCR investigations • Trained other analysts efficiently on analytical procedures to increase productivity and skill proficiency. • Wrote and revised formulation methods to improve documentations. Show less



Gilead Sciences

• United States
• Biotechnology Research
• 700 & Above Employee

• QC Chemist ( contract)

  • Jul 2014 - Jun 2015

  • Executed wet chemistry analyses on raw materials, stability and finished products per USP, EP and BP compendia. • Techniques employed as follows: Karl Fisher, DSC, TOC analyzer, UV-Vis spectrophotometer, pH and other wet chemistry fields. • Revised and reviewed analytical methods to facilitate method execution. • Executed wet chemistry analyses on raw materials, stability and finished products per USP, EP and BP compendia. • Techniques employed as follows: Karl Fisher, DSC, TOC analyzer, UV-Vis spectrophotometer, pH and other wet chemistry fields. • Revised and reviewed analytical methods to facilitate method execution.



Alliance Medical Products

• Senior Chemist ( contract)

  • Nov 2013 - May 2014

  • Conducted analytical and wet chemistry testing on raw materials, in-process samples, stability and finished products and special project samples. • Instruments operated as listed: HPLC, vapor pressure and freezing point osmometers, IR, TOC analyzer, conductivity meter, UV-Vis spectrophotometer, and pH meter. • Reviewed quality documents and provided technical comments. • Conducted analytical and wet chemistry testing on raw materials, in-process samples, stability and finished products and special project samples. • Instruments operated as listed: HPLC, vapor pressure and freezing point osmometers, IR, TOC analyzer, conductivity meter, UV-Vis spectrophotometer, and pH meter. • Reviewed quality documents and provided technical comments.



ISTA Pharmaceuticals (Products now under Bausch + Lomb, which was acquired by Valeant)

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Research Associate / Lab Safety Officer

  • Jul 2007 - Oct 2013

  • Performed analytical testing on new formulations from early to late phases, and drug products for stability and release utilizing HPLC and UV-Vis spectrophotometer.• Assisted in writing analytical methods, stability protocols and reports for new product/process formulation to establishing data to submit to FDA.• Revised analytical methods and SOP’s to improve document quality.• Reviewed data and supported QC group

• QC Analyst

  • Apr 2006 - Jul 2007

  • Conducted testing on API, raw materials and final products to meet batch release deadlines.• Helped write SOP’s and AP’s and reviewed data to meet QC goals.