Document Control Associate

Summary:

The Document Control Associate will assist with the day-to-day document control activities within the Quality Assurance department as well as other key departments at Neurocrine to ensure that all GxP-regulated documents are filed systematically and easily retrievable. Duties will include management of paper-based and electronic GxP records, lifecycle management of records, maintenance of the document control database, and troubleshooting document issues and requests. In addition, the Document Control Associate will be involved in data transfers to Neurocrine’s Electronic Document Management System (EDMS).

Essential Duties and Responsibilities (including, but are not limited to):

  • Maintain a document control management system compliant with regulatory, quality and company policies and requirements.
  • Responsible for the management of all documentation and records to include receiving, filing, and maintenance of all GxP documents, including but not limited to Standard Operating Procedures (SOPs), Quality Policies, and forms.
  • Maintain GxP audit files and assist with entry, tracking, and archiving of audit records.
  • Involved in controlled documents lifecycle and periodic review management.
  • Contribute to the creation and development of efficient processes, archiving, and operations related to document control.
  • Perform review of documents submitted through the change control process for format and style, completeness, and review and approvals.
  • Process document requests to be used in-house or sent to Contract Service Providers in a timely manner.
  • Assist staff regarding document control processes.
  • Provide key support for complex data transfer to the EDMS.
  • Other essential duties as assigned.

Qualifications:

  • Knowledge of document control and regulatory compliance requirements within a pharmaceutical or biotech environment.
  • Strong EDMS and computer skills to include Excel, Word, PowerPoint, Adobe Acrobat, OpenText CS10.
  • Knowledge of the eCTD model for regulatory submissions.
  • Able to interact effectively with stakeholders of various departments and manage multiple projects simultaneously.
  • Attention to detail, critical thinker, and exceptional organization skills required.
  • Eye for detail and able to function well independently as well as part of a team.
  • Strong communication skills.

Education and/or Experience:

  • B.S. Degree in a related scientific field desired.
  • A minimum of 5 years of experience within the pharmaceutical/biotech industry performing document control and document management activities.

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