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Quality Assurance Admin

  • Location: Boston
  • Salary: US$28.00 - US$35.00 per hour per hour
  • Job Type:Contract

Posted about 1 year ago

  • Sector: Engineering, Life Sciences
  • Contact: Melissa Steel
  • Duration: 6 months
  • Expiry Date: 02 June 2022
  • Job Ref: JN -042022-469443

Provides temporary administrative support for Quality Assurance processes as defined under Key Responsibilities below.

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

  • Creates Certificate of Analysis and Release data files within the electronic document management system (EDMS) and coordinates review with Quality representative
  • Performs Archival of QA Records in EDMS (e.g., CMO batch records, data packages)
  • Conduct follow up on Action Items for Quality Leadership Team (QLT) meetings
  • Assist with quarterly updates for Continuous Improvement Projects and Risk Trackers
  • Assist with generation of Metrics and Metrics reports
  • Performs Data Entry into GxP Regulated Systems as required
  • Manages events/CAPAs in electronic quality management system (EQMS), including data entry, tracking, and follow-ups with Owners to drive completion
  • Coordinates document approval and creates Docusign workflows, as necessary
  • Schedules and coordinates meetings for CMC Quality Operational team (Leadership meetings, Extend group meetings). Manages agenda and minutes and follows up on all action items