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QA Documentation Specialist
Title : QA Documentation Specialist - II
Documentation Specialist II
Required to come in the office at a minimum of 3 days per week ( Flexible schedule )
Required to take COVID 19 Test 2-10 days prior to assignment, and take a test from onsite or home every 2 weeks
Responsibilities:
• Ensures accuracy of paper record inventory on-site and off-site, e.g., binders stored on-site, wet-signed paper Original Records (executed forms and protocols) awaiting off-site archival and/or already being stored in off-site storage facility.
• Accepts receipt of paper records submitted for archival.
• Verifies the consistent application of Good Documentation Practices (GDP) in received paper records.
• Completes data entry of received paper records in records management system.
• Scans paper records, verifies completeness of electronic copies, and uploads electronic copies into Electronic Document Management System (EDMS), e.g., true copy certification process.
• Oversees the process for off-site archival of paper records, including filling vendor storage boxes, scheduling vendor pickup and record retrieval.
• Continuously updates records management system to track the status of a paper record in the archival process.
• Supports periodic audit of archived paper records.
• Works on assignments that are moderately complex in nature where ability to recognize deviation from accepted practice is required.
• Identifies deviations from document control procedures. Notifies IT management and assists with issue resolution.
• Provides paper record archival process metrics for management review.
• Provides support for internal and regulatory audits/inspections as required.
• As needed, provides support for processing of electronic documentation in EDMS
Knowledge, Experience and Skills:
• Demonstrates strong working knowledge of, and has extensive relevant experience with, managing paper records, including true electronic copy creation, archiving originals in off-site storage, and use of a records management system, such as FileTrail or similar (in a GxP environment is preferred).
• Demonstrates strong verbal, technical writing, and interpersonal skills.
• Demonstrates strong working knowledge of Document Control fundamentals, Quality Systems, and GxP requirements.
• Demonstrates strong working knowledge of Electronic Document Management Systems (EDMS), such as VeevaVault Quality Docs or similar (in a GxP environment is preferred), including relevant experience with managing and troubleshooting review/approval/obsoletion/retirement workflows and document classification/metadata.
• Demonstrates effective organizational, planning, and time management skills.
• Demonstrates high attention to detail, while service-oriented, with the ability to process high volumes of requests/paper record submissions and archival in a timely, prioritized and compliant manner.
• Demonstrates strong computer skills with software used in document processing, which includes MS Excel, Word, Adobe Acrobat.
• 3+ years of relevant experience in a regulated industry. Direct experience with documentation management in a GxP pharmaceutical setting is preferred, including extensive experience with GDP.