Quality Assurance Associate, Records Management

Position Summary:

The Quality Assurance Associate, Records Management supports all activities within the Records Management team, including administering the electronic Document Management System (eDMS), supporting the document revision process, controlled document issuance, archival, customer support, establishment of training courses within the eDMS, and logbook and data collection form control. This role will also cross-functionally support ongoing training activities as required to maintain compliance with internal and external regulations.

Principal Duties and Responsibilities: 

• Quality documentation processing in support of ongoing projects and daily GxP operations
  • Issuance of Controlled Copies, Batch Records, Logbooks, Lab Notebooks, and Data Collection Forms.
• Support document archive program
  • Maintain appropriate filing structure to keep archived material identified, secure, and easily retrievable when needed.
  • Maintain appropriate chain of custody for controlled documents submitted for archival.
  • Maintain archive database for accuracy of documentation details and location.
  • Retrieval of documentation upon internal customer request and during inspection activities.
  • Prepare and coordinate documentation transfer to offsite archive.
  • Support and advise end users on document system requirements and workflows.
  • Evaluate questions and issues received from end users, make decision on appropriate follow-up steps based on established processes, procedures and guidelines, and escalate to manager as appropriate.
• Support with enhancement to documentation control processes and systems
  • Identify opportunities for process and system improvement and enhancement.
  • Participate in quality and process improvement initiatives and project teams.
  • Provide support for internal/external audits and inspections.
  • Contribute to deviation investigations and CAPAs within scope.
• eDMS Administration
  • Assess document packets in eDMS to ensure compliance to applicable procedures, including document template, reviewer selection, appropriate change justification, training plan, etc.
  • Responsible for ensuring the administration of the eDMS system (MasterControl), including working with the provider to troubleshoot system issues
  • Improving and adding workflows as required
  • Creating new document types and templates
• Training Support
  • Generation and Maintenance of User Accounts in MasterControl
  • Function as the Qualified Instructor for various Quality related subject matters
  • Generating and performing user training
  • Create or update training course and exams within MasterControl associated with new and revising documents.
  • Assisting end users with proper completion of training tasks as required to maintain compliance

Qualifications:

• Associate’s degree or equivalent is required
• Minimum of 3 years previous experience in document management within a GxP environment, and minimum of 5 years working in a GMP environment is highly preferred
• Proficiency with MS Office, including Word, Excel, and PowerPoint
• Experience with technical writing a plus
• Experience with MasterControl or other electronic documentation and training management system
• Strong organizational and/or project management skills
• Solid written and verbal communication skills
• Sound communication skills and customer focus, with ability to interact in a cross functional organization
• Ability to work 5 days per week onsite in Bedford, MA in an office environment