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Document Control Specialist

Beam Therapeutics

Beam Therapeutics

Durham, NC, USA
Posted on Friday, January 19, 2024

Position Overview:

The Document Control Coordinator will report into the Global Quality Systems team and will support activities for global system document and training management. The position is important to Beam in support of broader organization moving products through the clinical pipeline to commercial launch and growth.

The Document Control Coordinator, will provide routine documentation support for global organization within Veeva which includes, but is not limited to, uploading procedural documents, attachments, workflow assistance, physical document archival processing, and training documentation support. This role will support key stakeholders to ensure compliance of programs to phase appropriate GxPs, global legal/regulatory requirements and applicable global policies.

Primary Responsibilities:

Perform as Veeva Coordinator including:

  • Executing workflow and effective document management for Controlled Documents.
  • Serving as a contact for basic technical questions relating to the use of the document management system globally.
  • Notifying staff of new, revised and withdrawn controlled documents.
  • Troubleshooting workflows and report generation.
  • Formatting when required.
  • Periodic review workflows, reporting and support.
  • Support system improvement initiatives to optimize the business processes and practices within Quality Systems.
  • Collaborate to resolve technical issues and communicate best practices.
  • Support development of harmonized/streamlined/standardized processes and supplemental documents (including Work Instruction creation or maintenance) governing management and usage of Quality Systems.
  • Drafts and reviews system-related SOPs and related documents.

Qualifications:

  • University degree in scientific discipline/Life Sciences preferred or equivalent experience in biotech or pharmaceutical industry.
  • 2+ years of relevant experience in a GxP environment.
  • Provides consistently prompt, efficient, dependable, highly skilled service.
  • Self-motivator with the ability to follow-up on and complete multiple projects simultaneously.
  • General knowledge of regulatory requirements for the pharmaceutical, biotechnology or vaccine industry.
  • Excellent interpersonal effectiveness, written/verbal communication, influencing and negotiation skills.
  • Ability to work independently.
  • Excellent computer skills and advanced knowledge of Quality Systems.
  • Direct experience with Quality Management Systems, Document Management Systems, Learning Management Systems, and Microsoft Office including Word and Excel.
  • Highly attentive to details and able to work well as part of a team.
  • Identifies and uses good judgement to handle out-of-compliance situations.
  • Good listening and communication skills.
  • Positive approach.
  • Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.