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Documentation Specialist - I (Assistant) (GMP Biopharma)

55 700$
Формат работы
onsite
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
US
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
Documentation Specialist - I (Assistant) (GMP Biopharma): Managing controlled documentation and archival records for a quality systems environment with an accent on Veeva document issuance, reconciliation, paper-record archiving, and Good Documentation Practices. Focus on maintaining inspection readiness, updating archival inventory systems, organizing SAP batch records, and guiding users through quality procedures.

Location: Durham, North Carolina, United States

Salary: $55,700 annually

Company

hirify.global provides staffing and employment services for technical and life sciences roles.

What you will do

  • Issue and reconcile controlled documents using Veeva and other electronic document management systems.
  • Archive paper documents in the High-Density Storage Room and update the Record Inventory Management System.
  • Process document check-out requests and organize paper batch records from SAP for issuance.
  • Support system owners in maintaining site inspection readiness and applying quality system procedures.
  • Enter data according to Good Documentation Practices and guide users on appropriate documentation processes.

Requirements

  • Bachelor’s degree preferred; an associate degree or high school diploma with two years of related GMP biopharma experience is also accepted.
  • Knowledge of Veeva or another electronic document management system.
  • Experience with archiving or organizing physical documents, data entry, and GMP practices.
  • Excellent written and verbal communication, collaboration, organization, and attention to detail.
  • Ability to escalate issues appropriately.

Culture & Benefits

  • Major medical, dental, vision, and 401(k) benefits are available for temporary assignments lasting 13 weeks or longer.
  • Statutory sick pay is provided where required.
  • Reasonable accommodations are available during the employment process.

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