In Process Quality Assurance for IV bag fluid manufacturing

QA COA approval for Manufactured Reference StandardsLaboratory Investigations/CAPALaboratory Equipment Quality approval for Maintenance/Calibration

Laboratory data review for the Research and Development Laboratories

Quality Auditor for Pre-Clinical and Clinical Contract StudiesDocument and Laboratory Data review and approval

QA for sterilization of Medical Devices

Quality Assurance for Scientific Laboratory Services: Stability/Reference Standards

Quality Assurance for Electrical Manufactured Products

Cell Culture/Purification*Performed Inoculation/maintenance/harvest of small/large cell cultures*Performed HPLC column chromatography & UF/DF operations*Proficiency in documentation review*Extensive experience analyzing both culture/protein samples*Maintained; calibrated; repaired analytical laboratory equipment*Process monitoring and execution using Delta V system*Maintained all departmental SOP book systems*Troubleshooting equipment problem and resolution*Experience in reviewing & revising standard operating procedures*Executed documentation; initiation; and investigation of deviations*Initiated sample submission; tracking; and testing with LIMS system*Worked on several Quality related projects*Performed environmental cleaning of clean room/equipment*Cleaned, sterilized process equipment CIP/SIP/COP*Initiated work orders; coordinated/assisted work with facilities*Trained several employees

QAL Sample Management*Performed routine sample distribution for testing*Document/check samples into logbooks/records*Aliquot; aseptic preparation of samples*Received; handled final product

Performed production support audits; reviewed logs & MBR’s*Conducted employee reviews/training; wrote/revised SOP’s*Implemented cleaning/documentation program*Documented deviation reports; equipment work orders*Trended departmental manufacturing activity reports*Responsible for 2nd shift Production Support operations*Assisted in the execution of validation protocols*Prepared small/large scale buffers/aseptic technique*Prepared employee reviews

Performed small scale cell culture in biosafety cabinet*Prepared QC laboratory solutions/media*Maintained stock inventory for lab in database

Purified protein using various column chromatography systems*Maintenance/harvest of small/large scale cell cultures*Sampled/aseptically prepared samples*Monitored columns/bioreactors/critical equipment*Reviewed, executed batch records*Performed CIP/SIP process equipment*Formulated large scale buffers; sterilized process equipment

Performed Environmental sanitization of Production Suites*Responsible for equipment cleaning/sterilization*Assisted with Fill/Finish BDS*All work performed under cGMP Regulations

Conducted small/large scale PCR for Human/Mouse Genome*Analyzed DNA through gel electrophoresis*Revised protocols; trained new employees