Job Description: Must haves: Experience in MS Office (Word, Excel, PowerPoint, etc.) Experience with document management systems, either manual or electronic. Electronic preferred. Experience archiving controlled/critical records. Experience in a regulated environment (Manufacturing, Food Industry, Medical Device, etc.)
Minimum HS diploma with related experience required. A B.S. degree (in Science, Engineering, or Biochemistry) is preferred. A minimum of 2 years of relevant experience including a minimum of 1 year of direct document management experience in a regulated environment focused on product quality. Strong teamwork and communication skills and the ability to follow written and verbal instructions. Knowledge of biotech bulk and finished product manufacturing, and analytical testing is highly desirable. Familiarity with US and EU cGMP regulations and guidance is required. Working knowledge of common computer systems such as MS Word and Excel is required. Experience with electronic document management systems, is preferred.
Quality - Document Coordinator • Devens, MA, United States
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