Bristol-Myers Squibb Company

Records Mgmt Specialist

Location
Devens, MA, US
Posted
Oct 12, 2018
Ref
R1510453
Required Education
Masters Degree/MBA
Position Type
Full time
The Records Management Specialist will manage the document change control process, coordinating cross functional reviews, approvals and effective targets in alignment with requirements (cGMP and BMS) and customer needs.

Responsibilities
  • Executes the initiation, processing, routing, distribution and archiving of cGMP documentation and facilitates the compliance of site documentation
  • Serves as a subject matter expert for the electronic document management system and electronic learning management system and provides system metrics as needed
  • Provides backroom support during in regulatory agency inspections and corporate audits including the provision of system reports
  • Manages and executes the initiation, processing, routing, distribution and archiving of training documentation and associated curricula updates
  • Performs training assessments for new/ revised documents and associated performance qualifications in alignment with requirements (cGMP and BMS) and customer needs
  • Conducts user training on the document management system and electronic learning management system, as needed

    Qualifications
  • A minimum of 4 or more years of relevant experience including a minimum of 2 years of document management or administrative / project coordination experience in a regulated environment focused on product quality is required
  • Strong customer service skills (collaboration and communication) and the ability to follow written and verbal instructions are required
  • Excellent computer skills and proficiency with MS Office is required
  • Ability to perform well in a team-based environment is required
  • Familiarity with applicable US and EU cGMP regulations and guidance is preferred
  • General knowledge of biologics manufacturing and testing concepts is highly desirable