Quality Assurance Specialist
1 week ago
Piper Companies is seeking a highly motivated Quality Assurance Specialist to oversee the revision, issuance, and tracking of controlled documents for a biotechnology company.
Key Responsibilities:
- Oversee the revision, development, and tracking of controlled documents
- Manage the full life cycle of all controlled documents in the Electronic Document Management System (EDMS) including document creation, archival, and revisions
- Maintain all document management files in the EDMS system
- Responsible for issuing batch records, logbooks, and other controlled forms/documents
- Collaborate with clients, quality assurance team, and other departments to assist in the revision, issuance of the documents
- Assist with distributing tracking numbers for the quality systems
- Handle all quality systems fundamentals including batch release, batch record review, batch record issuance, and all document control activities
- Review documents for accuracy, completeness, and compliance
Requirements:
- 2+ years of document control/document management experience working in a FDA-regulated industry (biotechnology, pharmaceutical, medical device, etc.)
- Strong experience working with Electronic Document Management Systems (EDMS) such as Master Control, Veeva, Agile
- Bachelor's degree in a science-related field
Benefits:
- Salary: Between $70,000 - $80,000 based on years of relevant experience
- Benefits: Medical, Dental, Vision Insurance & 401k Contributions
Keywords:
Document control, document management, document specialist, document control specialist, document control coordinator, quality assurance, EDMS, electronic data management system, Veeva, Master Control, MasterControl, FDA, biotech, pharma, issuing documents, batch records, batch disposition, document management system, logbooks, controlled documents, document archival, GMP, cGMP, current good manufacturing practice, good manufacturing practice, GxP, trackwise, QMS, quality management system, quality compliance, quality systems fundamentals
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