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Specialist, Quality Assurance Document Control

Durham, NC 27713

Posted: 05/31/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 565106 Is job remote?: No Country: United States

Job Description

Pay rate is $26.00 to $28.00
Job Profile Summary The Specialist, Quality Assurance Document Control, assists with issuance of documents, archival, scanning,

Job Description Responsibilities:
  • Leads and support process improvement projects associated with the document management & archival systems
  • Manages the preparation, routing, review, approval, distribution, and archival of new and revised controlled/managed documents.
  • Reviews documents submitted to ensure the correct use of templates, correctly entered metadata and document types.
  • Quality focused and works closely with SMEs to execute workflows and business processes that align with best practices.
  • Performs advanced word processing and assists personnel in resolving document format issues.
  • Ensures controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedure.
  • Provides guidance and advice on approved procedures, standardization and requirements associated with the document management system.
  • Collaborates with cross-functional departments to ensure timely implementation of document change requests.
  • Acts as liaison with Training department to coordinate the release of documents in the document management system with the learning management system (LMS).
  • Provides training to new staff on document management system and document management processes and procedures.
  • Supports audits (internal & external) in order to verify that regulatory and quality requirements have been met.
  • Organizes and ensures accurate and reliable filing systems for all paper based GxP documents.
  • Maintains SOP binders.
  • Other related job duties as assigned.

  • Bachelors degree and 3 years of technical writing/document control experience in the pharmaceutical/biotech industry or equivalent combination of related education and experience.
  • High attention to detail is required.
  • Works under minimal supervision; requires a high level of independence.
  • Excellent knowledge of understanding of applicable GxP regulations.
  • Experience with Electronic Document Management Systems and is proficient with the Microsoft Office suite (e.g., Word, Excel, Visio, PowerPoint) and Adobe.
  • Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
  • Effective written and oral communication skills.
  • Effective time management and interpersonal skills.
  • Possesses initiative and is proactive.
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