Document Management Coordinator

A Few Words About Us
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

• 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