Senior Associate, Records Management

Position Summary:

This Senior Associate is responsible for the processing, issuing, reconciling, and archiving of all GxP documentation at Ocular Therapeutix, as a key member of the Quality Assurance team. Additionally, they will maintain the company wide Electronic Document Management System (eDMS), MasterControl.

Primary Duties and Responsibilities:

• Function as the primary SME in MasterControl related to Documentation Change Controls
• Implement and Collaborate on Quality Events as required to determine Records Management impact and provide necessary assessments
• Update internal procedures as required to implement identified corrective actions related to Quality Events or Continuous Improvements
• Participate in all required internal and external audits
• Maintain Qualified Instructor (QI) Training and provide required training sessions to all required attendees for all Records Management related processes
• Maintain Training Compliance between 95 – 100% on all required processes.
• Function as a System Administrator for all Records Management owned systems.
• Function as the team lead as the Records Management and Training department continues to grow and develop
• Perform existing responsibilities as required to maintain business and department functionality
• Additional responsibilities as required

Requirements:

• Bachelor’s degree in relevant technical field 
• 2+ years of experience in technical writing or software documentation and Records Management
• Prior experience with eDMS, MasterControl preferred
• Proficiency in word processor programs such as Microsoft Word and Google Docs and PDF software such as Adobe Acrobat 
• Familiarity with systems development life cycle (SDLC)
• Excellent written and verbal communication skills
• Strong attention to detail, time management and organizational skills
• Healthy analytical and critical thinking skills
• Experience with both print and digital media formats
• Experience training co-workers and other personnel to assist in team growth and development

Working Conditions:

• Work is done in an office environment
• There may be flexibility to work from home intermittently after onboarding and training

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