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Scientific. Clinical. Software Engineering

Document Control Specialist

San Diego Metro Area, CA

Employment Type: Full-Time Job Type: Scientific Job Number: JN -012021-27918 Region: San Diego Metro Area

Job Description

Duties:

Provide exceptional customer service to company s internal and external customers in all assigned tasks.

Support the administration, and improvement of the Document Control system for the origination, revision, obsolescence and periodic review of controlled documents.

Issue and reconcile master documents to support manufacturing and operations such as master batch records, lab notebooks, logbooks, and controlled copies of documents maintained in Satellite Binders.

Support the management of vital records and reports maintained in the Document Control Vault (onsite) and archive files (offsite) in compliance with regulatory requirements and internal record retention policies.

Format controlled documents according to internal procedures prior to release for use.

Provide support and guidance to customers on activities under current scope of responsibility.

Write and/or implement changes to the Document Control system.

Support regulatory inspections and partner audits.

Other duties as assigned.


Skills:

Must have a foundational understanding of Document Control and GMP.

Ability to manage multiple responsibilities with a high degree of self-motivation.

Strong communication, interpersonal, and organizational skills.

Strong proficiency in Microsoft Excel, PowerPoint, and Word and Adobe Acrobat applications.

Prior experience with MasterControl, or similar electronic Document Management System, desirable.

Flexibility to work varying schedules to support occasional weekend, holiday and off shift work hours.


Education:

One-to-three years of relevant pharmaceutical industry, Quality Assurance, experience.

BS/BA degree in scientific or business discipline preferred but is not required.

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