Quality Control Specialist

frontage laboratories   Exton, PA   Full-time     Manufacturing / Production / Operations
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Posted on June 5, 2021

Quality Control Specialist for Frontage Laboratories, Inc. - Exton, PA, Perform quality review of biologics bioanalytical data (raw data & LIMS data), method development/qualification/validation reports & sample analysis reports to ensure compliance with protocol, SOPs & government regulations; 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, system suitability failure & deviations; serve as technical advisor for analysts with regard to QA/QC of data; develop quality-related document for projects.

Requirements: MS or foreign equivalent degree in Regulatory Affairs for Drugs, Biologics & Medical Devices or related field; 2 years experience as Quality Control Specialist or 2 years project management experience in CRO. Required experience to include ELISA, PCR amplification, post-reaction prep, sequencing data collecting & analysis, qPCR, DNA molecular cloning, transformation, sequencing, analysis 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 & requirements, 21 CFR Part 11, FDA, GCP requirements, LIMS software & maintenance of controlled documents, report writing for GLP, cGCP study, such as IND, NDA, ANDA, Annual report & PADER.