Position Summary:
Seeking a detail-oriented and tech-savvy Documentation Specialist to support GI Development sites and activities. This role focuses on electronic document management, records migration, and user support within a regulated environment. The ideal candidate will act as a subject matter expert for document management systems and ensure efficient migration from legacy platforms.
Key Responsibilities:
- Serve as a subject matter expert for electronic document management systems (EDMS), including controlled and regulatory submission documents.
- Configure document templates and workflows within document management platforms.
- Provide first-line support and troubleshooting for Development users.
- Manage the migration of records from legacy systems to approved document management platforms.
- Follow precise system instructions and processes with high attention to detail and minimal supervision.
- Balance multiple priorities across concurrent documentation and migration activities.
- Ensure compliance with 21CFR Part 11, GLP (FDA & EPA), GMP (FDA & EU), VICH, and internal policies on Records and Information Management.
- Create and maintain clear, accurate documentation of processes and activities.
- Understand and apply industry best practices in pharmaceutical and/or biological development documentation.
Preferred Skills & Tools:
- Veeva Systems (preferred)
- Documentum
- Microsoft Teams
- Microsoft SharePoint
- Experience working in a regulated laboratory environment
- Familiarity with electronic recordkeeping in compliance with regulatory standards
Required Qualifications:
- Bachelor’s degree + 2 years relevant experience, OR
- Associate’s degree + 2 years experience, OR
- 4 years of relevant experience without a degree.
Key Competencies:
- High attention to detail and process adherence
- Strong problem-solving skills and technical aptitude
- Ability to manage multiple tasks simultaneously
- Clear communication skills and documentation abilities
- Understanding of pharmaceutical/biological development processes (preferred)
Job Type: Full-time
Pay: From $20.00 per hour
Schedule:
- 8 hour shift
Application Question(s):
- How many years of experience do you have working with electronic document management systems?
- Have you worked in a regulated environment (pharmaceutical, biotech, FDA/EPA regulated labs, etc.)?
- What is your highest level of education completed?
- Which document management platforms are you familiar with?
Work Location: On the road