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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Salary Range
$98,000-$110,000 USD
