Job Details

  • Title: QA Technical Operations Lead
  • Code: RCI-30949-1
  • Location: Devens Massachusetts (MA) 01434
  • Posted Date: 03/24/2020
  • Duration: 6 Months
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  Job Description

Responsibilities:

  • May provide Quality support of technical services programs.
  • Provides quality support to Devens Site through quality review and approval of investigations and change controls.
  • Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of the manufacturing process including, incoming, manufacturing, facility, and utility systems.
  • Assures consistent, effective use of the site change control system for all change requests.
  • Ensures supporting documentation and change deliverables meet external regulatory and internal WWQC guidelines and requirements.
  • Represents QA in cross-functional meetings

Qualifications:
  • Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
  • Knowledge of science generally attained through studies resulting in a B.S. in Science, Engineering, Biochemistry or related discipline or its equivalent is preferred
  • Knowledge of US and EU cGMP regulations and guidance.

Knowledge of electronic systems including any of the following:
  • Past experience where one was required to work in a team based environment with a diverse group of people.
  • SAP, LIMS, TrackWise, SmartLAB and Syncade desirable.
  • Excellent writing and oral communication skills are required.