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Document Coordinator

  • Location: Massachusetts
  • Job Type:Contract

Posted 6 days ago

  • Expiry Date: 22 October 2022
  • Referral:

Job Description: 

  • Manages and executes the initiation, processing, routing, distribution and archiving of cGMP documentation. 

  • Manages the document change control process, coordinating cross-functional reviews, approvals and effective dates in alignment with requirements (cGMP) and customer needs 

  • Serves as a subject matter expert for the electronic document management system. 

  • May assist in user training on the electronic document management system. 

  • Provides Records Management support during regulatory agency inspections and corporate audits. 

Education and skills: 

  • Minimum HS diploma with related experience required. A B.S. degree (in Science, Engineering, 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, 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. 

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.