• 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