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Document Management Coordinator

Integrated Resources, Inc

Lexington, Massachusetts

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Administrative Skills, Biotech and Pharmaceutical, Clinical Research, Code of Federal Regulations, Current Good Manufacturing Practice (cGMP), Customer Relations, Data Entry, Detail Oriented, Document Management, Documentation, Documentation Review, GxP, High School Diploma, Information Technology & Information Systems, Microsoft Excel, Microsoft Office, Microsoft Word, Multitasking, Operations, Organizational Skills, Problem Solving Skills, Process Control Engineering, Reconciliation, Rehabilitation Nursing, Standard Operating Procedures (SOP)
LOCATION
Lexington, Massachusetts
POSTED
2 days ago
Document Management CoordinatorA 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.Job DescriptionThe 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 SheetsWork to include routine administrative duties to support compliance, control and retrieval of the various documentsOvertime may be required on weekdays and weekendsSome 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 practicesFormatting to structure record and data entry workCreate, 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 reportsEfficiently 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 820High level of proficiency with MS Office applications, including Word, Excel and Power PointExperience with database manipulation and data extraction; familiarity with software such as MasterControl. Must be able to read, understand, speak and write (print) legibly in EnglishHighly organized and detail oriented approach to work/task managementQualificationsAbility to manage numerous priorities simultaneously; deliverables must be accurate and timelyProactive approach to customer servicePerform effectively as member of a team and as an independent contributorDemonstrate strong problem-solving skillsAble to work independently, at times with minimal instructionCapable of sound and proactive decision making, seeking clarification as appropriate to minimize/eliminate delaysEffectively embrace change, take risks and build mutual trust..Help process documents using master controlSOP's, Procedures, Work Instructions, Etc. (any time of documentation)Microsoft Office Skills are requiredMaster Control experience is required (Electronic Document Management System)Must come from a Pharma/Biotech BackgroundBachelors Preferred-not RequiredRequires a high school diploma and a minimum of 0-2 years previous experience working in a cGMP/GXP environmentAdditional InformationThanksWarm RegardsRickyI'm interested

About the Company

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Integrated Resources, Inc