Quality Assurance Associate, Records Management

Ocular Therapeutix•Bedford, MA

10d•Onsite

About The Position

Ocular Therapeutix, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapies for eye diseases using its proprietary ELUTYX™ technology. The company aims to be a leader in the ophthalmic space and fosters a strong culture of creativity and collaboration at its headquarters in Bedford, MA. The Quality Assurance Associate, Records Management will support the Records Management team by administering the electronic Document Management System (eDMS), assisting with document revisions, controlled document issuance, archival, customer support, training course establishment, and logbook/data collection form control. This role will also support ongoing training activities to ensure compliance with regulations.

Requirements

Associate’s degree or equivalent is required
Minimum of 3 years previous experience in document management within a GxP environment
Proficiency with MS Office, including Word, Excel, and PowerPoint
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

Nice To Haves

minimum of 5 years working in a GMP environment is highly preferred
Experience with technical writing a plus

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.
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
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

Benefits

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.

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