QA Document Control Specialist - R&D Partners

Essential Functions and Responsibilities

• Independently manage and monitor the processing, review, and approval of revision- controlled documents in the Electronic Document Management System (eDMS).
• Ensure compliance with controlled document format and content.
• Maintain master documents and records (both hardcopy and electronic) to ensure documentation is retrievable and files are accurate, complete, and well organized.
• Manage the document periodic review process.
• Issuance of batch records, forms, logbooks, validation documents, labels, and other controlled documents as required.
• Provides support for internal and regulatory audits and inspections as required.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.

Required Education, Skills, and Knowledge

• Bachelor s degree in Life Sciences discipline
• 2+ years demonstrating MS Office Suite and Archival skills
• Proficient in an eDMS system and document formatting
• Must possess a high level of attention to detail and proficient in Word and Excel.
• Familiarity with document change management and FDA quality systems