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QA Document Control Specialist
Philadelphia Metro Area, PA US
2024-03-28
2024-05-15
Job Type: Scientific
Job Number: JN -032024-32328
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
- 1-2+ 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