QA Associate

Devens, Massachusetts
Industry: QA Testers
Job Number: JN -062021-65409

Job Description :

  • Executes quality assurance activities in the incoming material process such as inspection/review of consumables and raw materials.
  • Performs quality review for area documents including GMP forms, logbooks and batch records.
  • Provides floor support of warehouse and cryogenics functional areas, including walkthroughs and inspection readiness activities, on a day to day basis.
  • Assist with the lifecycle management of material qualifications, including reduced testing and direct dispense.
  • Assists quality assessment of Supplier Change Notifications for impact to site.
  • Assists in discrepancy reporting, deviations and CAPAs associated with nonconforming/defect material.
  • Assists/Owns CAPA execution and drives actions through to completion.

 

Requirements:

  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, related discipline, or its equivalent.
  • A minimum of 2 year with directly relevant experience in a regulated environment is required.
  • Basic knowledge of regulated activities such as Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).
  • Demonstrate proficiency in common computer tools such as word processing, spreadsheet and web based applications.
  • Past experience where one was required to work in a team based environment with a diverse group of people.
  • Previous work experience where attention to detail and personal accountability were critical to success.
  • Strong communication skills and the ability to follow written and verbal instructions.


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