- Location
- Bedford, MA · Head Office
- Department
- IT
- Seniority
- Entry
- Experience
- 2+ years
Description
Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.
Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.
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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Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.
