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2 дня назад

Senior Technical Writer (Quality Control)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US/Denmark
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Senior Technical Writer (Quality Control): Designing and improving QC document creation, revision, approval, and change-control processes for API, IFP, and OFP documents with an accent on clear technical language, document governance, and GMP compliance. Focus on coaching authors and subject-matter experts, standardizing documentation, coordinating cross-functional stakeholders, and delivering projects against metrics and timelines.

Location: Clayton, North Carolina, United States; onsite work in an open office environment. Travel of up to 10% may be required.

Company

hirify.global is a global healthcare company developing medicines and solutions for diabetes, obesity, rare blood, and endocrine disorders.

What you will do

  • Design and own processes for implementing new API, IFP, and OFP QC documents, including change control, training assessment, routing, and approval.
  • Improve revision processes for QC documents while maintaining compliance and ease of use.
  • Review local QC documents for clear, reader-friendly language and support authors with writing, document control, and related tools.
  • Lead, train, coach, and mentor QC technical writers and subject-matter experts.
  • Collaborate cross-functionally and participate in SOP expert networks, process workshops, and document governance groups.
  • Support QC standardization projects and ensure project metrics and timelines are achieved.

Requirements

  • Bachelor's degree or an equivalent combination of education and experience.
  • At least five years of technical writing experience, preferably in engineering, life sciences, software, or a related field.
  • Ability to read, write, and understand complex product documentation and standard operating procedures.
  • Knowledge of core work processes and GMP concepts.
  • Strong planning, organization, execution, communication, and stakeholder-management skills.
  • Ability to work onsite in Clayton, North Carolina, in an open office environment.

Nice to have

  • Knowledge of LEAN or other process improvement methodologies.
  • Experience with change management at hirify.global.
  • Experience planning and scheduling complex problems solved by cross-functional teams.

Culture & Benefits

  • 14 paid holidays.
  • Mentorship and career development opportunities.
  • Work with multiple sites and cultures across the world.
  • Inclusive recruitment and equal employment opportunity.

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