Biopharmaceutical Technical Writer

6 days ago

Syracuse, New York, United States Trinity Consultants - Advent Engineering Full time

Job Summary

Trinity Consultants - Advent Engineering is seeking a skilled Biopharmaceutical Technical Writer to join our team. As a Biopharmaceutical Technical Writer, you will be responsible for creating and editing Standard Operating Procedures and Work Instructions, liaising with Change management in the creation and execution of Change Controls, and monitoring and executing of Corrective and Preventative Actions (CAPAs).

Key Responsibilities

  • Develop and maintain technical documentation for biopharmaceutical processes and systems.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
  • Analyze and interpret data to identify trends and areas for improvement.
  • Design and implement data visualization tools to enhance department communications.
  • Support existing dashboards and reporting, such as KPI initiatives.
  • Develop metrics to support existing and new processes.
  • Collaborate with subject matter experts within the Facilities department and across the company.
  • Communicate progress in the form of metrics and project summaries.
  • Provide coordination support during regulatory inspections and partner audits.
  • Participate in ongoing inspection readiness activities.

Requirements

  • Experience with Quality Systems.
  • Strong analytical skills with attention to detail.
  • Excellent written, verbal, and interpersonal communication skills.
  • Ability to work independently within a tight deadline environment.
  • Handle multiple projects simultaneously.
  • Experience with data visualization software (Qlik, Tableau, Spotfire, etc.) preferred.
  • Experience with SQL preferred.
  • Experience with a statistical computing language such as R preferred.
  • Experience with SharePoint Lists and Workflows preferred.
  • Six Sigma Black Belt, or Operational excellence certification preferred.
  • Experience with CMMS system preferred.
  • Project Management Experience.

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