Technical Writer

 

Description:

We are seeking a detail-oriented and experienced Technical Writer to support Cell Therapy labelling operations in a regulated GMP environment. The ideal candidate will have a background in life sciences or technical documentation, and experience managing documentation and label development using EDMS and ERP systems like Oracle or SAP.

 

Key Responsibilities

  • Author, revise, and manage Standard Operating Procedures (SOPs) and specifications for GMP labelling.
  • Complete intake forms and track item creation by coordinating with cross-functional teams.
  • Conduct interviews with subject matter experts and translate their input into actionable documentation (e.g., Work Instructions, Job Aids).
  • Schedule and facilitate meetings to gather feedback, draft documents, manage reviews, and drive approvals.
  • Upload and manage documents using Electronic Document Management Systems (EDMS).
  • Maintain a document periodic review calendar, ensuring timely completion of reviews and updates.
  • Maintain up-to-date understanding of GMP regulations and ensure documentation is compliant.

 

Qualifications

Must-Haves:

  • Bachelor’s degree required (Life Sciences preferred).
  • 1–3 years of experience working in a GMP environment.
  • Familiarity with GMP labelling requirements.
  • Proficient in Microsoft Word, Outlook, Teams, SharePoint, and EDMS.
  • Experience with Oracle and/or SAP systems.
  • Strong organizational and communication skills.

Organization Confidential
Industry Other Jobs Jobs
Occupational Category Technical Writer
Job Location Washington,USA
Shift Type Morning
Job Type Full Time
Gender No Preference
Career Level Intermediate
Experience 1 Year
Posted at 2025-04-14 10:18 pm
Expires on 2025-07-18