Position Summary

The Documentation Specialist I is a regular employee in a full-time position at Kashiv BioSciences, LLC, in Piscataway, NJ. The employee is responsible for review, issuance, control of procedures, forms, test methods and reconciliation throughout the organization. The Documentation Specialist will assist on maintaining 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      documentation and ensure documents are properly archived 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. 
• Manage      a broad spectrum of projects to support the needs of Quality Management.
• Perform      other duties and responsibilities as delegated by Quality Management.

 PREREQUISITES:

Education:

· A bachelor’s degree from a four-year university/college in life science, computer science, or other related field; or 5 + years of experience 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.