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GMP Technical Writer

4 months ago

Bothell, United States LanceSoft, Inc. Full time

Job Title: Quality - Technical writer

Location: Bothell, WA 98021

Duration: 11 months


Job Description:


Top skills:

  • Minimum of 5-8 years’ experience in a GMP laboratory environment.
  • At least 5 years’ experience in writing and reviewing standard operating procedures.
  • Experience with Veeva EDMS preferred, or similar
  • Experience with ERP, SAP Preferred, revising, or creating new documents.
  • Experience working cross functionally, communication and customer service skills.


Key Responsibilities and Major Duties

  • Write and revise standard operating procedures (SOPs) for GMP Analytical and Microbiology laboratory operation and instruments.
  • Ability to interview cross functional subject matter experts and translate their description into actionable instructions- Work Instructions, Job Aids using the templates prescribed by corporate policy.
  • Schedule cross functional team meetings, collect feedback, create draft documents, post on SharePoint, schedule reviews, collect and resolve feedback.
  • Knowledge of electronic document management systems (EDMS) to complete workflow of document to final approval by uploading the word document into EDMS.
  • Prepare SOP periodic review timetable and ensure the review/approval or retirement are completed in support of the procedure lifecycle in timely manner.
  • Work independently but recognize need to consult stake holders and keep them informed of progress.
  • Identify and lead improvement efforts within current procedures.
  • Maintain a good understanding of ICH Guidelines, regulations and other guidelines applicable to GMPs.
  • Ability to negotiate and influence solutions without direct authority.
  • A self-starter with an ability to manage electronic systems with minimal training and supervision.


Requirements:

  • Minimum of 5-8 years’ experience in a GMP laboratory environment.
  • At least 5 years’ experience in writing and reviewing standard operating procedures.
  • Experience with Veeva EDMS preferred, or similar
  • Experience with ERP, SAP Preferred, revising, or creating new documents.
  • Experience with microbiology testing is a plus.
  • Demonstrated ability to successfully manage competing deadlines and balance priorities.
  • Excellent technical writing skills, close attention to detail and excellent follow up.
  • Expertise in Microsoft Word and Share Point.
  • Proficient in Microsoft outlook, MS team meetings, Share point, EDMS. Able to conduct video conference calls via MS teams 4-6 hours a day.