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