GENERAL SUMMARY OF POSITION:
Reporting to Facility Manager, Documentation Specialist II will be responsible for coordinating activities related to providing required documentation and implementing related documentation systems. Documentation Specialist II will coordinate the review and revision of procedures, specifications and forms. In addition, will assists in developing and maintaining computerized and hardcopy files to support all documentation systems. This position will specialize in either the Technical Document system or the Work Order system.
This position is located at Fall River.
Please visit our website for more information:
www. Massbiologics. org
+ Maintains Engineering related paper and electronic master documentation files. Works with clerks to perform scanning activities for archiving and retrieval.
+ Using MASTERControl, creates, edits, issues and revises documents for Facilities Technical Documentation and Work Orders including drawings, SOPs, specifications, vendor documentation, forms, memos, and reports. Assures that said documentation is the correct revision when issued. Determines using SOP and best judgment when revisions to drawings are necessary.
+ Coordinates periodic review process for all technical documents.
+ Creates and organizes systems for filing and tracking GMP related records and documentation. Maintains indices for drawings, specs and vendor documentation and assures that physical organization of these documents agrees with the indices.
+ Assists in distribution and maintenance of paper and electronic documents. Access databases are utilized for the tracking and management of the high volume of documentation flowing between MBLs related departments and the construction firm involved in the project.
+ Reviews documents to ensure that cGMP documentation meets in-house and cGMP requirements.
+ Maintains proficiency in Microsoft Word and Microsoft Access programs. Working knowledge of Microsoft Excel program is advantageous. Adept at learning new computer programs such as CMMS quickly.
+ Maintains security of documentation storage to prevent unauthorized use or loss of documents.
+ Requires a Bachelors degree or equivalent with a minimum of 2 to 5 years of related experience in documentation, engineering technical writing or equivalent.
+ Normally receives no instructions on routine work, general instructions on new assignments.
+ Computer literate and in-depth knowledge of MS Office programs. Must have a working knowledge of design of relational databases.
+ Works on problems of diverse scope where analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined practices and policies in selecting methods and techniques for obtaining solutions.
+ Must have excellent verbal and written communication skills.
+ Ability to focus on detail while still retaining concept of large picture
+ Ability to work independently and to prioritize work
+ Excellent proof reading skills
+ Attention to detail is critical
+ Must be able to learn technical details associated with Validation protocols and Engineering SOPs.
+ Must be able to follow all current Good Manufacturing Practices.
+ Willingness to learn new software systems. Limited travel for training purposes is required.
This position is located at Fall River.
Requisition Number: 2015-25647
Exempt/Non-Exempt Status: Non Exempt
Company Name (Integration): MASSBIOLOGICS
External Company Name: University of Massachusetts Medical School
External Company URL: www. umassmed. edu
UMass Medical School is committed to being an equal opportunity and affirmative action employer and recognizes the power of a diverse community. We encourage applications from protected veterans, individuals with disabilities and those with varied experiences, perspectives and backgrounds to consider UMass Medical School as their employer of choice.
Review of applications will begin immediately and the position will remain open until filled.
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