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Associate I, Quality Control


Location: Norwood , Massachusetts
Job Category:

The Role

The individual in this role will perform cGMP QC release and stability testing and laboratory support functions.

This individual may support special projects as assigned.

This role will be Monday through Friday, working second shift from 2:00 pm to 10:00 pm.

Here's What You'll Do:

  • Performs routine analytical chemistry testing including HPLC, UPLC, UV, Particle Analysis and Dynamic Light Scattering
  • Supports special projects as assigned
  • May assist with troubleshooting assay methods and equipment
  • Performs data entry and supports trending
  • Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc
  • Supports authoring of SOPs, protocols and reports
  • LIMS (LabVantage) sample result entry, execution of Electronic Assay Forms in LIMS
  • Perform HPLC (AEX) and NaOH plate reader based assays in support of manufacturing process stat testing as needed
  • Stability program support
  • Supports more junior staff with data review, training and troubleshooting
  • Managing/stocking of QC lab supplies
  • Write/revise SOPs, protocols and reports
  • Complete and maintain cGMP documentation for work performed.
  • Participate in authoring quality systems records such as deviations, change controls, CAPAs
  • Establish and maintain a safe laboratory working environment

 

Here's What You'll Bring to the Table:

  • BA/BS in a relevant scientific discipline with at least 1 year experience; or years in a laboratory setting with focus in analytical chemistry
  • General laboratory operations (Pipette use, pH, reagent prep, etc.)
  • Technical writing
  • Proficiency with Microsoft Office Programs
  • Familiarity with electronic databases (e.g. LIMS, SAP, LMS
  • Practical working knowledge of QC instrumentation and related software
  • Strong written and oral communication skills as well as organizational skills
  • Knowledge of industry standards and guidelines
  • Demonstrated ability to work effectively under established guidelines and instructions
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
  • Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment

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