QA Document Control Specialist

Philadelphia Metro Area, PA

Job Type: Scientific Job Number: JN -022024-32204 Region: Philadelphia Metro Area

Job Description

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

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