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Technical Writer

PeopleSuite Talent Solutions
Hunt Valley, MD
  • Posted: over a month ago
  • Full-Time
Job Description

Scope of Position


Manage and prepare project documents with the supervision of the Supervisor of Technical Writing, Analytical R&D

Responsibilities

  • Work directly with Analytical R&D and Quality Control team leads, as well as clients to author method validation protocols and reports.
  • Manage and prepare project documents with the supervision of the Supervisor of Technical Writing.
  • Assist with the writing of test methods and protocols for the validation of test methods.
  • Write validation reports.
  • Assist in the preparation/revision of appropriate SOPs for the department.
  • Coordinate and communicate with project managers on the status of technical documents.
  • Other writing job duties, as assigned

Qualifications

  • BS is chemistry or related physical/biological science with 1 or more years of writing experience.
  • Knowledge of CGMP regulations in a pharmaceutical laboratory environment.
  • Working knowledge of scientific principles for various analytical techniques, such as high performance liquid chromatography (HPLC), gas chromatography (GC), and titrations.
  • Advanced knowledge of FDA guidance for industry for Analytical Procedures and Methods Validation and ICH Q2 Validation of Analytical Procedures
  • Computer literacy and ability to use processing software.
  • Must be proficient in communication skills with the ability to write good quality reports.

PeopleSuite Talent Solutions

Address

Hunt Valley, MD
USA

Industry

Education

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