Senior QC Analyst

2 weeks ago


Durham, United States KBI Biopharma Full time

This role contains the following responsibilities covering 2nd shift hours (2:00 pm through 10:30 pm), Monday through Friday:Position Summary:The Senior QC Analyst (2nd Shift) will be trained to execute analytical test methods and their corresponding analytical techniques. The core function is composed of completing QC testing for in-process, characterization, release, or stability samples. Additionally, when need arises, Senior QC Analyst will assist with troubleshooting and support In-process Support Associates with STAT samples during 2nd shift.Responsibilities include:In-process, characterization, stability, and/or release testing as assigned. Capabilities include (but not limited to) HPLC, ELISA, qPCR, SoloVPE, other spectrophotometric techniques, capillary electrophoretic techniques, and compendial testing per USP with near-zero error and minimal guidance or directionExecution of method transfer, method qualification, and/or method validation testing performed under protocolSolution preparationOrganizes and processes samples according to GxP standardsIndependent analysis and collation of data to draw conclusionsEnter data into control charts and LIMS, if applicableSupports lab investigation and deviation reportsSupports implementation of Corrective and Preventive ActionsRevises SOPs and technical documentsSupports team to troubleshoot testing or project challenges with comfort in presenting and communicating dataTracks department metrics upon request; actively engages in improvement of department metricsPartakes in continuous improvement projects or leading simple improvement projectsEnsures state of safety and regulatory audit readiness at all timesMaintains work to current Good Manufacturing Practices (cGMP)Ensures Trainer qualification status to expand team matrixLaboratory support – ensures areas are neat, clean, organized, and equipment is functioningParticipates in data review activitiesDuties may include support in STAT testing coordinationIt is the expectation that this position is required to be onsite full time with a minimum of 75% of time in the laboratory/facilityMinimum Requirements: Relevant degree and 4-8 years’ biopharmaceutical industry experience, preferably in protein analyticsSalary: $63,000-$86,900



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