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Manufacturing Document Specialist
Ref No.: 18-05027
Location: Carlsbad, California
Job Title:Manufacturing Document Specialist
Duration: One year
Location: Carlsbad, CA
Job ID: TMO-REQ-004454

Technical document specialist is required to implement a new documentation system by converting manufacturing instructions from batch records/SOPs/WINs into EBR (Electronic Batch Record) forms.

* Sets up and maintains EBR system to capture all record control requirements, including maintenance of files, quality assurance, information conversions, and systems automation
* Edit or modify policies and procedures for the EBR system
* Requires working closely with other team members to prioritize workload evenly as well as review data collected by others to ensure accuracy
* Opportunity to identify improvements to the EBR system and work with developers to design, test and validate improvements
* Willingness to train new EBR system users as needed

* The successful incumbent will possess a Bachelor's Degree in Biology, Molecular Biology, Chemistry or other related discipline in order to effectively interpret the current manufacturing documents
* 1-2 years' highly preferred experience with data entry working with large data sets utilizing Excel
* Experience can be from a previous job, internship, project, etc.
* Comfortable working with formulas
* Excellent verbal and written communication skills
* Be details oriented
* A versatile skill set, that includes the ability to adjust to a dynamic department's needs.
* Proficient in MS-Office, Excel, Word, Power Point
* Basic understanding of ISO 9001 guidelines