обновлено 1 час назад
Documentation Specialist - I (Assistant) (GMP Biopharma)
55 700$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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