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Associate I, Quality Control (3rd shift Wed-Sat)

Norwood, MA 02062

Posted: 01/11/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 538996 Is job remote?: No Country: United States

Job Description


Job Description

Seeking a contractor for Quality Control Associate I position based at their Norwood, MA site. The individual in this role will perform cGMP QC testing for QC Chemistry. The position will be 3rd shift to cover Wed-Sat rotation and may require off-shift hours.

Duties:
  • Performs routine analytical chemistry testing including HPLC, UPLC, UV, Particle Analysis and Dynamic Light Scattering.
  • Performs data entry and supports data review as assigned.
  • Performs general laboratory support activities including reagent preparation, equipment maintenance, lab housekeeping etc.
  • Write/revise SOPs, technical protocols and reports.
  • Works with and within the LIMS system to record data and associated testing details.
  • Perform HPLC (AEX) and NaOH plate reader-based assays in support of manufacturing process stat testing as needed.
  • Supports sample management activities including sample retrieval/ receipt, sample logging, aliquoting and distribution.
  • Orders, Manages and monitors stocking of QC lab supplies
  • Complete and maintain cGMP documentation for work performed.
  • Establish and maintain a safe laboratory working environment.
  • Support testing for raw materials, intermediates, drug substance and drug product, including generation of testing data to support clinical studies.
  • Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements.
  • May assist with equipment qualification / validation activities, including maintenance.
  • May troubleshoot issues related to equipment, laboratory procedures and assay performance.

Requirements:
  • BS in a relevant scientific discipline
  • At least 1 year of relevant experience in a cGMP organization with a focus on GMP testing

Preferred:
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Pay Range: 25-35/hr
Salary will be commensurate with experience
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