Senior Associate, Records Management
Ocular Therapeutix, Inc. · Bedford, MA · Yesterday
On-siteOTHR$98k/yrFull-time
About the role
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. They will maintain the company-wide Electronic Document Management System (eDMS), MasterControl.
Responsibilities
- Function as the primary SME in MasterControl related to Documentation Change Controls
- Implement and collaborate on Quality Events 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 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 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
Pay
Salary Range: $98,000 USD - $110,000 USD