2 дня назад
Senior Technical Writer (Quality Control)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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 .
- 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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