Document Management Coordinator

• The Candidate will conduct daily documentation processing using Master Control in support of ongoing projects and daily operations including, but not limited to; SOPs, 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

• Overtime may be required on weekdays and weekends

• Some travel between Alewife and Lexington sites may be necessary. (Personal transportation is required). 

Responsibilities-

• Process controlled documentation within the customers 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) 

• 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 MasterControl. Must be able to read, understand, speak and write (print) legibly in English

• Highly organized and detail oriented approach to work/task management

• 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..

• Help process documents using master control

• SOP’s, Procedures, Work Instructions, Etc. (any time of documentation)

• Microsoft Office Skills are required

• Master Control experience is required (Electronic Document Management System)

• Must come from a Pharma/Biotech Background

• Bachelors Preferred-not Required

• Requires a high school diploma and a minimum of 0-2 years previous experience working in a cGMP/GXP environment

Thanks

Warm Regards

Ricky