Anju Chib Email & Phone Number

United States

Newark Ca

Alameda Ca

Formulated very complex molecular diagnostic bulks following established protocols and SOPs efficiently and precisely in GMP and QSR regulated manufacturing environment .(2X PCR Master Mix, Dipoles, Viral Lysis buffer, Sequincing bulks, 5'-Phosphorylated Oligonucleotide 9(probes), beads, chimerism plates) Dispensed bulks manualy (200-300 tubes)or automatic by monobloc (2000-3000 tubes) torqued them using torque equipment and used side labeler to label them.Maintained manufacturing lab equipment charts, calibrations, BVP on analytical balances, environmental monitoring and particle counts, manufacturing supplies.Experienced in GMP,GLP, Clean room (gowning- de gowning), ISO13485, 21CRF820 for medical devices, internal and external audits. Running manual, semi-automatic and automatic lab equipments in GMP environment. Review Manufacturing batch records, initiated and investigated non conformance reports, assisted validation processes and process improvement.Resolved and supported the team in solving work problems on the floor.Lead the manufacturing team in the absence of managers and communicated, coordinated with production planner, QC, QA ware house departments for timely and successfully completion of production orders and their shipment.Trained manufacturing team and other internal groups.Experienced in SAP, batch record reviewing, SOPs writing, excel, MS word.

Run assay - Amplification-Linearization-blocking- hybridization on cluster generation machine-Cbot,PCRFormulated the reagents and buffers for GNR runs,clustering DNA and performed Fluidic troubleshooting QC of DNA clusters by taking images of clusters in each channel of flow cell on manteia (Fluorescent microscope).Run assay using software LIMS to Coat/ Graft on GNR machineQC the flow cells for their intensity analysis on Typhoon.Performed equipment maintenance and repair.

Accurately labeled and aliquot chemical and Oligonucleotide inventory samples using GMP methods as defined in SOPsWorked in collaboration with production planning, manufacturing and quality control to manage and direct the flow of materials through the supply chainIdentified potential issues and implemented corrective actions in order to ensure adherence to the production schedule.Used GMP guidelines to manage logistics for proper storage and handling of chemical inventory pre and post production Compiled and composed inventory metrics provided to administration and monitored cycle count of inventory as per SAP system.