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Document Management Coordinator
Ref No.: 18-03043
Location: Cambridge, Massachusetts
Position Type:Contract
Start Date / End Date: 06/04/2018 to 03/03/2019
Job Title: Document Management Coordinator
Job Location: Cambridge, MA
Job Duration: 9 Months

The Candidate will conduct daily documentation processing in support of ongoing projects and daily operations including, but not limited to; SOP's, Batch Records, Material Specifications, Product Specifications, and Formulation Preparation Sheets. Work to include routine administrative duties to support compliance, control and retrieval of the various documents. Some travel between Alewife and Lexington sites may be necessary. (Personal transportation is required).

Process controlled documentation within the customer?s system. (60% time) Review documentation packages for accuracy and conformance to established guidelines, polices, and practices. Formatting to structure record and data entry work. Create, maintain, and support on-site/off-site informational customer resources. (30% time) Advise and respond to queries on document status by interfacing with customers. (5% time) Data extraction, manipulation of data for reports. Efficiently and effectively organize assigned projects for issuance, reconciliation and communicate statuses. (5% time)

Requires a high school diploma and a minimum of 0-2 years previous experience working in a cGMP/GXP environment. Has knowledge and general aspects of Document Management with a broad understanding of 21 CFR parts 210 & 211 and 820. High level of proficiency with MS Office applications, including Word, Excel and Power Point. Experience with database manipulation and data extraction; familiarity with software such as File Maker Pro. Must be able to read, understand, speak and write (print) legibly in English. Highly organized and detail oriented approach to work/task management. Key Abilities/Competencies: Ability to manage numerous priorities simultaneously; deliverables must be accurate and timely. Proactive approach to customer service. Perform effectively as member of a team and as an independent contributor. Demonstrate strong problem-solving skills. Able to work independently, at times with minimal instruction. Capable of sound and proactive decision making, seeking clarification as appropriate to minimize/eliminate delays. Effectively embrace change, take risks and build mutual trust..