Ocular Therapeutix, Inc Quality Systems Specialist II in Bedford, Massachusetts
The Quality Systems Specialist II supports all activities within the Quality Systems team, including CAPA, Deviation and Change Control, and with a special focus on Document Control and Training. This includes, administering MasterControl, the electronic Document Management System (eDMS), supporting the document revision process, controlled document issuance, customer support, and establishment of training courses within the eDMS.
MasterControl (eDMS) administration.
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, generating and performing user training, setting up and generating reports/ad-hoc reports. The position will support with upgrades and be a key participant in a project to expand the eDMS into an eQMS for CAPA, Change Control, Deviations and Supplier Quality.
Quality documentation processing in support of ongoing projects and daily GxP operations.
Assess document packets in the eDMS to ensure compliance to applicable procedures, including document template, reviewer selection, appropriate change justification, training plan, etc.
Create or update training course and exams within MasterControl associated with new and revising documents.
Advising users on document system requirements and workflows.
Proactively understand and enhance end user experiences. Evaluate questions and issues received from end users, make decision on appropriate follow-up steps based on established processes, procedures and guidelines.
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 owned by Quality Systems team.
Experience with MasterControl is highly preferred.
Other electronic documentation and training management system or eQMS
Bachelor’s degree or equivalent.
Minimum of 2 years previous experience in document management in a GxP environment, and minimum of 3 years working in a GMP environment.
Proficiency with MS Office, including Word
Positive attitude and team skills are a must.
Strong organizational and/or project management skills.
Solid written and verbal communication skills, experience with technical writing a plus.
Sound communication skills and customer focus, with ability to interact in a cross functional organization.
External Company Name: Ocular Therapeutix, Inc.
External Company URL: http://www.ocutx.com/
Street: 36 Crosby Drive