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.