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Technical Writer

2 months ago

prairie, United States Medasource Full time

Responsibilities:

Provide support for Parenteral Operations by researching, organizing, writing, editing, and formatting technical information to produce high-quality documents.


Key Objectives / Deliverables:

  • Creating and revising standard operating procedures, work instructions, forms, and other controlled documents to communicate complex technical information in a clear and concise manner.
  • Perform gap assessments between global and local procedures to identify areas that require remediation or continuous improvement.
  • Utilize completed gap assessments to revise or create controlled documents.
  • Collaborating with subject matter experts and technical staff to create or revise controlled documentation.
  • Ensuring that the written content meets the needs of its intended audience.
  • Responsible for the timely closure of assigned quality records.
  • Serve as document administrator within the electronic Quality Management System (eQMS), MasterControl.
  • Process document changes and management of changes while ensuring good documentation practices (GDP) within the eQMS, MasterControl, and compliance to Nexus Pharmaceutical’s procedures.
  • Perform initial change control requests for proper workflow and change control documentation requirements within MasterControl.
  • Act as contact person for troubleshooting record workflow through MasterControl change control process.
  • Perform document control review following area manager and QA approval to ensure proper formatting.
  • Launch new documents within MasterControl to assist with document change control lifecycles.
  • Manage and ensure compliance to record retention policy.
  • Schedule and track the periodic review of controlled documents.
  • Maintain and issue logbooks to Operations, Engineering, Micro/QC Laboratories as needed.
  • Maintain, issue, and reconcile serialized forms.
  • Other duties as assigned.


Basic Requirements:

Education

  • 4-year bachelor’s degree in science-related strongly preferred. (Additional GMP Quality Experience may be accepted in lieu of degree)

Experience

  • 3+ years of relevant experience. Pharmaceutical preferred.
  • Knowledge of Microsoft Office Suite Programs required.
  • Familiarity with digital QMS systems, MasterControl preferred.


Additional Skills/Preferences:

  • Specific skill set: quality minded, critical thinking, technical writing, problem solving, experience in investigative techniques, highly detail oriented, and highly organized
  • Ability to communicate clearly and concisely when conveying information, summarizing facts, asking questions, etc.
  • Must be able to work independently
  • Strong organizational skills