Document Processor II

Post Date

Feb 27, 2023

Location

Cambridge,
Massachusetts

ZIP/Postal Code

02141
US
Sep 19, 2024 Insight Global

Job Type

Contract

Category

Specialist

Req #

VMS-PHI-PHHJP00021494

Pay Rate

$42 - $51 (hourly estimate)

Job Description

Document Control and Training Specialist

In this role you have the opportunity to
Lead global project execution and provide recommendations to management and business category leaders for Hospital Patient Monitoring HPM for projects including but not limited to Legal Manufacturing Consolidation and QMS Simplification. This position will work within a global network to communicate and address challenges related to strategic transformation and consolidation projects while driving standardization and compliance in the Business Group.

You are responsible for
  • Establishing and providing document control support to authors and process owners in defining and producing lean Quality System documents and records
  • Ensuring and providing direction regarding proper quality of the content of documentation and records
  • Establishing and managing proper document review processes
  • Ensuring availability and publishing of controlled documents
  • Establishing monitoring and responding to metrics on the efficacy and efficiency of the document management system and its ability to support the business
  • Collecting and maintaining documents and records of the latest revision level
  • Timely distribution of latest revision level documents and records to appropriate users and ensuring that obsolete documentation is removed from distribution and publication
  • Maintaining the document management system an ensuring fast retrieval of documents and records
  • Controlling issuance of document numbers including maintenance of proper document registers
  • Ensuring proper document classification sorting filing and archiving in accordance with requirements
  • Reviewing correct formatting and completeness of documentation
  • Responsible for preparing document transmittals
  • Archiving Quality records per process
  • Accountable for transformation-related strategic initiatives supporting the PQMS structure
  • Ensures the addition and management of any local QMS documents in line with the evolution of the PQMS
  • Ensures training and training registration as per the QMS and generates training content for QMS documents as necessary
  • Approve each training material prior to usage and control the set and recording of approved trainings
  • Ensure that training content is controlled and access to make changes is managed
  • Ensure the assignment of training requirements profiles and documentation for all job required training
  • Ensure that managers assign the correct training profiles to all individual employees based on job requirement profiles
  • Report on training compliance and training related KPIs
  • Ensure all mandatory training requirements are set and training is executed as required
  • Administer both profiles and training records in line with regulatory requirements
  • Ensure Training Management System setup in accordance with transformation of the QMS

    To succeed in this role you should have the following skills and experience
  • Bachelors degree in a scientific or technical field or medical device certifications
  • 3 years of experience in the medical device industry or similar work experience
  • Strong working knowledge of GMPs and other FDA regulations
  • Project Management Skills preferred
  • Experience validating application activities.
  • Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues.
  • Experience in corrective and preventive actions including root cause analysis documenting findings/actions and implementing actions.
  • Proven analytical capabilities
  • Excellent communication organizational and project management skills
  • Successful experience working with cross-functional teams across multiple work locations
  • Network oriented and able to interact with different business functions and can work within numerous systems
  • Work cooperatively in a team environment

    **Must be available to work East Coast Hours
    **Remote position**

    Experience: 2-5 years of experience in position or specialization. Education: High-school/Associates or equivalent experience if applicable. Certification if applicable. Open sort and route incoming mail answer correspondence and prepare outgoing mail. Complete and mail bills contracts policies invoices and checks. Compile copy sort and file records of office activities. Answer phones direct calls and take messages. Operate office machines photocopiers and scanners facsimile machines voice mail systems and personal computers.
  • Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.