Job Details

  • Title: Technical Writer
  • Code: RCI-PFE-15771-1
  • Location: Andover Massachusetts (MA) 01810
  • Posted Date: 06/12/2019
  • Duration: 12 Months
  • Status: Open
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  Job Description

This role will provide non-testing support for raw material testing for new and existing products in a cGMP Quality Control Analytical (QCA) department. This support includes writing and revising technical documents (procedures, test methods, raw material specifications) for new and existing raw material, LabWare Laboratory Information Management System (LIMS) support, visual management, and continuous improvement. The candidate will be responsible for documentation support as an individual and through collaboration with laboratory subject matter experts (SMEs). Organize and prioritize workload with the manager to meet all timelines and deliverables in the support of the plan of record and to ensure compliance.

Responsibilities:

  • Revise and author GMP documents
  • Create and submit change requests to laboratory information management system (LIMS) builds to LIMS team and review work completed
  • Support continuous improvement projects and actions
  • Manage projects and coordinate timelines with stakeholders
Education and Experience:
  • A BA/BS degree in science, engineering, computer science, or related technical discipline
  • Minimum 3-5 years pharmaceutical/biopharmaceutical experience in a relevant GMP role such as QC or QA
  • Past experience working with QC documentation in the biopharmaceutical field is preferredĀ 
Technical Skills:
  • Proficiency with computer systems (Microsoft Office applications, etc.)
  • Experience with electronic document systems is highly preferred
  • Knowledge and understanding of cGMP and industry standards
  • Experience working in cGMP USP/EP/JP, regulatory environment strongly preferred
  • A detail-oriented approach to deliverables as the main job responsibility is the generation and revision of GMP documentation
  • Strong oral and written communication skills
  • Ability to work in a matrix environment
  • Ability to adapt to change in priorities and timelines
  • Dedicated and team orientated who is highly motivated and takes initiative, seeks out assignments