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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.

Requirements:
  • 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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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