Quality Control Specialist

  • Real Staffing
  • Cambridge, MA, USA
  • Dec 09, 2020

Job Description

Quality Control SpecialistDescription:We are seeking a talented Quality Control Specialist II to join our client 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 be a key team member and lead in the areas of continuous improvement projects, laboratory investigations, deviations and troubleshooting of aberrant data and equipment malfunctions.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 ELSdetections, 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 packages and equipment qualification packages * Identify and troubleshoot aberrant data and laboratory equipment malfunctions* Leads complex investigations, root cause determinations and instrument failure investigations* Maintain and troubleshoot various pieces of validated lab equipment including HPLCs* Identify laboratory continuous improvement projects and lead implementation initiatives* Independently support various additional quality systems including unplanned events, CAPA and change controls* Support preparation and revision of SOPs through identification of boundaries and gaps* May train other analysts on chemistry and analytical techniques* May cross-train on micro-biological lab techniques* May perform analytical method validations and method transfers for small molecule API formulationsEducation:* B.S. or M.S. degree in Chemistry, Analytical Chemistry, Biology (or a related field)Technical Experience:* Must have 5+ years of pharmaceutical experience in a QC or related lab testing function; Preferred 7-9+ years of professional experience in a GMP quality control lab and/or analytical lab* Expertise in GMP documentation and pharmaceutical quality systems required* 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 laboratory required * Experience with HPLC ELS detection highly desirable* Working experience with Waters Empower3 chromatography software strongly preferred Sthree US is acting as an Employment Business in relation to this vacancy.