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Lab QC Specialist

Company: Careerbuilder-US
Location: Boston
Posted on: April 10, 2021

Job Description:

Job Title: QC SpecialistLocation: Cambridge, MADuration: 10+ month contractPay Rate: $35-55/hrWe are seeking a talented Quality Control Specialist I to join our team in Cambridge! Your primary responsibility as a laboratory analyst will be to perform all aspects of chemistry-based laboratory testing in support of the in-process, release and stability testing for a commercial small molecule API parenteral liposome formulation. You will also assist in the process of continuous improvement projects, laboratory investigations, deviations and troubleshooting of aberrant data and equipment malfunctions. Job Requirements:Responsibilities* Independently perform in-process and routine testing for small molecule API parental drug product and lipid raw materials using a variety of HPLC based and chemistry methods in a GMP lab; HPLC with UV, RI and ELS detections, particle size distribution and zeta potential analysis, in-vitro release assays, pH, osmolality, UV-Vis* Perform daily calibrations and equipment checks to support daily lab testing* Execute all laboratory functions per defined procedures in full compliance GMP standards with close attention to detail and minimal analyst-generated errors* Perform peer technical review of analytical data and review equipment qualification packages* Perform analytical method validations and method transfers for small molecule API formulations* Identify and troubleshoot aberrant data and lead simple lab investigations with minimal oversight* Maintain and troubleshoot various pieces of validated lab equipment including HPLCs* Support and contribute to laboratory continuous improvement projects* Participate in and support various additional quality systems including unplanned events, CAPA and change controls* May train junior analysts on chemistry and analytical techniques* May cross-train on micro-biological lab techniques* May perform analytical method validations and method transfersQualificationsEducation:* B.S. or M.S. degree in Chemistry, Analytical Chemistry, Biology (or a related field)Technical Experience:* 5-7+ years of professional experience in a GMP quality control lab and/or analytical lab* In-depth knowledgeable and first-hand experience with most or all the following techniques: Reversed-phase HPLC, HPLC with ELSD detection, HPLC with RI detection, dissolution and in-vitro release assays, particle size, zeta potential, pH, osmolality and other standard wet chemistry methods* Experience in a GMP compliant function strongly preferred* Working experience with Waters Empower3 chromatography software strongly preferred

Keywords: Careerbuilder-US, Boston , Lab QC Specialist, Healthcare , Boston, Massachusetts

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