What are the responsibilities and job description for the Documentation Specialist I position at Kashiv BioSciences, LLC?
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The Documentation Specialist is a regular employee in a full-time position at Kashiv BioSciences, LLC, in Chicago, IL. The employee is responsible for review, issuance, control of procedures, forms, test methods and reconciliation throughout the organization. The Documentation Specialist will also assist to maintain the employees training files and training curriculum, to ensure employees remain current in assigned training.
Essential Duties & Responsibilities
- Issue and control, but not limited to Master Batch Records, Controlled Forms, Logbooks, Test methods, Protocols and Reports.
- Issue and route Documents Change Request (DCRs) in the Electronic Document System.
- Assist on scanning all batch records, validation documentation, calibration information, and supporting documentation and post on the company portal as needed.
- Perform audit of issued Controlled Forms, Master Batch Records, and Logbooks to finalize reconciliation and ensure timely return of documents for final archival.
- Receive, File and maintain document archives, to ensure documents are easily retrievable.
- Ensure documents are properly formatted.
- Responsible for template management to ensure harmonization among documents within the organization.
- Track and trend lead-times for Document Change Requests.
- Provided weekly status updates to upper management for all pending document reviews in the Electronic Document System.
- Provides Help Desk support to users of the documentation system. This includes creation and monitoring of incident tickets requiring help desk support from the Electronic Document System Administrator.
- Assists change originators in coordination of document releases.
- Responsible for identifying and implementing efficiency improvements to the overall document control process.
- Assist the training team by tracking and trending training files to complete training modules.
- Upload PDF versions of procedures to corporate portal and iPads.
- Manage a broad spectrum of projects to support the needs of Quality Management.
- Perform other duties and responsibilities as delegated by Quality Management.
Education:
- A bachelor’s degree from a four-year university/college in life science, computer science, or other related field; or commensurate experience (7 years) in a training and/or document control capacity, preferably in cGMP regulated industry
Experience:
- Previous experience working in a training capacity is desired. Experience commensurate with position level.
- Previous experience with electronic document management systems is desired Experience commensurate with position level.
- Previous work in a cGMP industry is desired
Certifications, Licenses, etc.:
- MasterControl™ Electronic Document Management System Operation certification is preferred
Work Environment & Physical Demands:
General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines.
Supervisory Responsibility, if any: No
This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.
