Audit Validation Customer complaints CAPAProcess improvements Continue Improvement

• Perform Problem Recognitions (PRs) and Corrective action and Preventive action (CAPA) for the regulated and non-regulated diagnostic products related to customer complaints, process validation and process improvement using Track Wise software.• Lead, drive, maintain and assist project management, project plans and schedules on time.• Improve document review process and work as a document control approval (DCA) for the document review and creating new documents such as Standard Operating Procedures (SOPs), WINs (Working instructions) and Forms using the Agile software.• Perform batch record review for the raw materials and for the finish products and release them using EI and SAP system. • Auditing and validating Manufacturing department such as cleanroom, diagnostic instruments including HPLC, GC-MS, Spectrophotometer, PH meters following company’s standards, FDA -21 CRF 210, 211,820, 821 and ISO 13485 standards.

• Corrective action and preventive action (CAPA) related to FDA observations, customer complaints, process validation, process improvement and product design. • Writing and implementing Standard Operating Procedures (SOPs) related to process improvement, process validation, product quality check, environmental monitoring, FDA ( 21CFR-820) and ISO 13845 regulations and standards.

•Identifying and implementing process improvement initiatives that improve workflow and productivity using Six Sigma technology and knowledge.•Supervise QA techs and acting as an advocate and an auditor for GLP/GMP practices as well as routine quality monitoring within the company, in research and commercial environments.•leading and investigating quality issues that may arise, reporting them to management, implementing corrective actions and identifying departmental strengths and weaknesses.•Ensure compliance with relevant regulatory and standards agencies regulations and guidelines, including FDA, CLSI and Company’s Standard Operating Procedure (SOP).•Validate the proper gama radiation dosage using Method 1 Validation of Radiation Sterilization of the Associate for Advancement of Medical Instrumentation (AAMI).•To certify the products regarding DNA free, DNA inhibitor free, ATP free (Adenosine Tri-Phosphate), Dnase/ Rnase free and Pyrogen free; several bio-molecular assays are performed and monitored including Bioburdon, Limulus amebocyte lysate (LAL), Sterility,UV/VIS spectrophotometer, PCR and Gas chromatography–mass spectrometry (GC-MS).•Testing raw materials and finish goods using FTR, TC plate, refractometer , viscosity, titration, dry content, PH meter, sterile water using Ozone and UV combination, air quality monitor and so on.

Investigating risk factors (aflatoxin and HBV) relate to liver cancer in Shanghai, China population. Several protocols have been followed including •Molecular Cloning and DNA isolation to make recombinant Plasmid•DNA isolation from human serum•Picogreen to measure DNA concentration •Real Time PCR/ PCR to investigate the mutation in codon 249 of the TP53 gene•Real Time PCR to quantify Line 1 DNA in cancer patients and regular people

• Developed monoclonal antibody for allergic patients using Mammalian cells, media, bioreactors and filtration.• Performed fermentation using yeast, antigen, bioreactors and centrifuge to develop vaccine.• Followed and practiced SOPs, GMPs, GLPs and managed the lab.

Investigated the inactivation of prion infectivity by reactive oxygen species (ROS). Our research group was able to eliminate prion infectivity by a precise measured dose of Ozone. To accomplish this study, following procedures had been performed• Cell Culture (Vero, Raji, & Jurkart, N2a)• Ozonated N2a cells at 1200 ppmv for 1 hour by a bio-instrument developed by the Lipidviro Tech, Inc company• Digested non-infectious prion with proteinase K• Assayed for infectious prion with Cell and Western blot

Checked the bacterial present in samples including ham, burger paddy and ice-cream using Elisa assay and rapid testMade plates and seeded the plates with diluted samples to check bacterial present including Salmonella, E. coli 0157 etcKept proper documentation for QA/QC purposeMaintained internal procedures and supporting SOP documents

• Performed western blots analysis and protein isolation to study the RecA protein expression• Performed PCR to amplify the SSB gene to study the mitochondrial-targeted SSB gene expression in different plants• Completed RNA isolation and Northern blots analysis to measure 23S rRNA expression in soybean and tobacco plants• Achieved chloroplast and mitochondrial isolation from Arabidopsis, Soybean and Turnip plants to study the DNA recombination and replication using high speed centrifuge and chromatography • Planted and harvested seed, Sterilized dishes for different lab uses