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QC Chemist II

Company: Summit Biosciences Inc.
Location: Lexington
Posted on: October 11, 2019

Job Description:

Summary:Responsible for independently performing routine tasks in the QC Chemistry laboratory.
Essential Duties:Perform incoming raw material sampling and testing, component inspection, in-process analyses, finished product release testing and stability testing.Maintain the laboratory in accordance with SOPs.Calibrate, operate and maintain analytical instrumentation for product testing, including routine preventive maintenance and troubleshooting.Write, revise and review Standard Operating Procedures, Material Specifications, Forms, Protocols and Reports.Familiar with basic analytical techniques and executes tasks under supervision or under the direction of a test method, standard operating procedure, or a protocol. Instrumentation includes: HPLC, UV/Vis, FTIR, GC and other high-tech instrumentation.Nasal Spray testingDevelop method validation knowledge.Develop instrument qualification knowledge.Develop understanding of cGMPs.Develop investigative skills for OOS, OOT and aberrant result laboratory investigations.Good oral and written communication skills.Recommend and implement as required, innovative approaches to problem solving.Other duties as assigned.
Knowledge, skills and abilities:Outstanding capabilities for multitasking and adjusting priorities in response to changing conditions and schedules.Team player with well-developed interpersonal, organizational, and communication skills.Maintains proper social etiquette and self-control when dealing with stressful situations. Minimum Qualifications:Degree in chemistry, pharmaceutics or related field; advanced degree is a plusExperience in analytical and drug product development activities regulated by FDAExperience with nasal spray drug product development and characterization is a plus

Keywords: Summit Biosciences Inc., Lexington , QC Chemist II, Other , Lexington, Kentucky

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