Quality Control Specialist

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Quality Control Specialist For Frontage Laboratories, Inc. - Exton, PA, prfm quality review of biologics bioanalytical data (raw data & LIMS data), method dvlpmnt/qualification/validation reports & sample anlys reports to ensure compliance w/ protocol, SOPs & gov regs; prep bioanalytical test rslt data tables for method dvlpmnt/qualification/validation reports & sample anlys reports using Excel, Watson LIMS or applicable sw; review study data packages & files prior to study finalization & archival; monitor lab compliance w/ respect to expired reagents, reagent labeling, lab cleanliness, training records, PPE adherence & cGXP to minimize lab audit findings; review GLP data for adherence to GLP regs; review & verify invalid data & sys suitability failures, resolve exceptions under non-routine events, sys suitability failure & deviations; serve as technical advisor for analysts w/ regard to QA/QC of data; dvlp quality-related doc for projects. Rqmts: MS or foreign equiv deg in Regulatory Affairs for Drugs, Biologics & Med Devices or rlt fld; 2 yrs exp as Quality Control Specialist or 2 yrs project mgmt exp in CRO. Rqrd exp to include ELISA, PCR amplification, post-reaction prep, sequencing data collecting & anlys, qPCR, DNA molecular cloning, transformation, sequencing, anlys of assays, isolation & purification of DNA, RNA & protein from biological samples; proficiency in Elisa, Simoa, PCR, Watson MSD, Ella, MALDI-TOF Mass Spectra, Gel Electrophoresis, ISO 9001:2015 & ISO 27001:2013 standards & rqmts, 21 CFR Part 11, FDA, GCP rqmts, LIMS sw & maint of controlled docs, report writing for GLP, cGCP study, such as IND, NDA, ANDA, Annual report & PADER. Full job & apply at https://www.frontagelab.com/about/careers/. Click to apply at: https://www.frontagelab.com/about/careers/ recblid gqluv7e166vtrbfn149lz4jremtm2r
Quality Control Specialist For Frontage Laboratories, Inc. - Exton, PA, prfm quality review of biologics bioanalytical data (raw data & LIMS data), method dvlpmnt/qualification/validation reports & sample anlys reports to ensure compliance w/ protocol, SOPs & gov regs; prep bioanalytical test rslt data tables for method dvlpmnt/qualification/validation reports & sample anlys reports using Excel, Watson LIMS or applicable sw; review study data packages & files prior to study finalization & archival; monitor lab compliance w/ respect to expired reagents, reagent labeling, lab cleanliness, training records, PPE adherence & cGXP to minimize lab audit findings; review GLP data for adherence to GLP regs; review & verify invalid data & sys suitability failures, resolve exceptions under non-routine events, sys suitability failure & deviations; serve as technical advisor for analysts w/ regard to QA/QC of data; dvlp quality-related doc for projects. Rqmts: MS or foreign equiv deg in Regulatory Affairs for Drugs, Biologics & Med Devices or rlt fld; 2 yrs exp as Quality Control Specialist or 2 yrs project mgmt exp in CRO. Rqrd exp to include ELISA, PCR amplification, post-reaction prep, sequencing data collecting & anlys, qPCR, DNA molecular cloning, transformation, sequencing, anlys of assays, isolation & purification of DNA, RNA & protein from biological samples; proficiency in Elisa, Simoa, PCR, Watson MSD, Ella, MALDI-TOF Mass Spectra, Gel Electrophoresis, ISO 9001:2015 & ISO 27001:2013 standards & rqmts, 21 CFR Part 11, FDA, GCP rqmts, LIMS sw & maint of controlled docs, report writing for GLP, cGCP study, such as IND, NDA, ANDA, Annual report & PADER. Full job & apply at https://www.frontagelab.com/about/careers/. Click to apply at: https://www.frontagelab.com/about/careers/ recblid gqluv7e166vtrbfn149lz4jremtm2r
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