Documentation Specialist-In Office

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Job Details

The Quality Support Coordinator Provides administrative and operational support for quality-related processes, including performance tracking, reporting, and coordination of internal and external feedback.

Hours: 1st shift 8am-430pm
Days: Monday-Friday

Job Requirements:

• 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• Maintain internal viewing or document repositories by uploading current versions and removing outdated revisions.

Qualifications

• 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) a plus

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