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BLENDING TECHNICAL REPORT WRITER

Company: Formulated Solutions
Location: Largo
Posted on: October 19, 2020

Job Description:

PRIMARY PURPOSE:Create new or revise existing content for regulatory documentation in accordance with industry best practices, cGMP requirements and corporate guidelines. Work collaboratively with project team members including Manufacturing, Engineering, Process Development, Quality and other subject-matter experts to solidify content.
MAJOR DUTIES AND RESPONSIBILITIES:

  • Creation of Batch records, SOPs, change requests, process validation protocols and equipment qualification protocols.
  • Review current documentation and recommend revisions or changes in scope, format, content, and methodology.
  • Edit, standardize, or make changes to material prepared by other writers or establishment personnel.
  • Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style, and terminology.
  • Understand different user levels and write documents that meet the need of the end user.
  • On new projects, provide updates on document deliverables to project management and ensure that documents are delivered to the customer (either internal or external) in a timely manner.
  • Performing other duties as assigned. QUALIFICATION:
  • Required (Experience in cGMP environment is preferred. The ability to communicate well with others through speech and prose is an absolute requirement. The technical writer must also be able to process complex thoughts and communicate them efficiently to the end user. Must be able to work independently as well as in a team environment.
  • Preferred Additional: Good command of MS Office Suite (Word, Excel, PowerPoint, and Outlook). Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation. Bachelor Degree in Science preferred. COMPUTER SKILLS: Proficient with use of Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) Education and/or TrainingAny related GDP and GMP training. B.S. Degree Preferred; High School Diploma or equivalent required. PI124916065

Keywords: Formulated Solutions, Largo , BLENDING TECHNICAL REPORT WRITER, IT / Software / Systems , Largo, Florida

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