Documentation Specialist
Jobot Consulting · Indianapolis, IN · 1 wk ago
On-siteAdministrative$22–$25/hrContract
Join a top company in the Medical Device industry as a Quality Support Coordinator, providing administrative and operational support for quality-related processes.
About us
Join a leading company in the Medical Device industry offering comprehensive benefits and professional growth opportunities.
Responsibilities
- Ensure all documents meet regulatory requirements, quality standards, and internal procedures before release.
- Scan, organize, and maintain both physical and digital files, including archiving historical records for long-term retention.
- Manage user access, permissions, and system integrity within internal document control or ERP systems.
- Schedule recurring and ad-hoc meetings as requested by internal departments to support workflow needs.
- Review documents for formatting accuracy, compliance, and proper version control.
- Collaborate with cross-functional teams to support document workflows, resolve discrepancies, and maintain consistency across documentation practices.
- Maintain record retention timelines and ensure documentation is accessible for internal and external audits.
- Process approved changes promptly, including updating information within internal ERP or document control systems.
- Maintain internal viewing or document repositories by uploading current versions and removing outdated revisions.
Requirements
- Computer skills: Excel, Word, PowerPoint, Access, Outlook.
- Familiarity with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP), as well as general regulatory expectations for controlled documents and records.
- Understanding of document control principles aligned with standards such as CFR 820.40 (Document Control) and ISO 13485 sections related to document and record management (e.g., 4.2.3, 4.2.4, 4.2.5) is preferred.
- Bilingual (English/Spanish) is a plus.
Benefits
- Medical, dental, and vision insurance.
- 401(k) and company match.
- PTO/vacation policy.
- Paid holidays.
- Bonus programs.
- Tuition reimbursement/training.
Pay
$22 - $25 per hour
Schedule
1st shift: 8:00 AM - 4:30 PM, Monday - Friday