Quality Assurance Document ControllerMedasource • Durham, NC, United States

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Quality Assurance Document Controller

Medasource • Durham, NC, United States

Hace más de 30 días

Tipo de contrato

Temporal

Descripción del trabajo

QA Document Controller

Duration : 18 month contract with probability of extensions or conversion

Schedule : M-F, 8-5 plus adhoc off hours / weekend support per business needs

Location : Durham, NC

Description :

The Document Controller supports document management for the issuance, distribution, reconciliation, labeling, and filing of GMP documentation for the Client Library Site. This role ensures compliance with Client GMP document requirements and supports the full scope of Library Support Services as defined by site management.

Key Responsibilities :

Record Management

Maintain Client Library Site document inventory control through the Record Manager (LRM) system in accordance with applicable SOPs.
Ensure accurate control and tracking of all GMP documents.

Document Control

Perform document control activities for all Client Site documents and records maintained in Client’s Veeva Quality Docs Electronic Data Management System (EDMS).

Training

Complete all required Client training and maintain compliance with documentation and records management procedures.

Route & Distribute Documents

Assist with routing, updating, and approval of electronic documents according to applicable SOPs and Client personnel requirements.

Veeva Workflow Oversight

Manage and monitor assigned Veeva Vault Quality Docs workflows daily.

Review Documents & Update Metadata

Meet with internal personnel as needed to review documents and update Veeva Quality Docs metadata when adding documents into the system.

Records Retention

Manage retention of GMP records in accordance with document type, record class codes, and Client retention policies.

Prepare and manage shipment of records to off-site storage for long-term retention when required.

Reconciliation

Facilitate the reconciliation process for executable electronic and paper records according to applicable SOPs.

Maintain Signature Logs

Oversee and complete annual department signature logs.

Logbook Creation & Issuance

Bind, issue, and maintain physical logbooks; support reconciliation of paper logbooks per SOP requirements.

Labeling & Coding

Label and code files for storage in on-site Documentation Centers.

Audit Support

Support internal and external audits by providing readily accessible records.

Assist with additional staffing or extended hours if requested in relation to audits, in alignment with Work Order terms.

Site Self-Inspection Support

Support self-inspections by ensuring documentation and records are compliant and accessible within Veeva Vault EDMS.

Document Periodic Reviews

Monitor and conduct periodic document reviews per SOPs and management direction.

Library Document Support

Work closely with Quality, Learning and Development, and other site business areas to capture and support document needs.

Periodically update documents in accordance with applicable SOPs.

Issue Escalation

Escalate issues to contractor leads or Client management as appropriate.

SOP Compliance

Follow all applicable Client GMP Standard Operating Procedures and report any compliance concerns in a timely manner.

Qualifications

BA / BS degree or equivalent experience

1–3 years of relevant experience in the pharmaceutical / biopharmaceutical industry (preferred)

General understanding of basic GDP principles and GMP environments

Strong proficiency with Microsoft Office applications

Familiarity with office equipment (copier, scanner, fax, etc.)

Proficient with Document Routing System workflow functionality

Ability to climb stairs, bend, and reach for filing; lift up to 30 lbs. as needed to move / organize file boxes

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Quality Assurance Document Controller • Durham, NC, United States

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