Senior Associate, Quality Systems

Replimune•Framingham, MA

5d•$101,500 - $131,500•Onsite

About The Position

This position provides cross-functional support of GXP activities as they relate to Quality Systems. This position will participate in the improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness. This position is based in our Framingham location and typically has a 5-day on-site expectation.

Requirements

Highly motivated individual with excellent time management skills.
Strong organizational skills with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail.
Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
Proficient in Microsoft suite (Word, Excel, PowerPoint, Access and Outlook).
Excellent written and oral communication skills.
Ethical, self-motivated and self-directed.
Ability to lift boxes <15lbs
Bachelor's degree with practical experience in a regulated manufacturing environment or equivalent experience
A minimum of 4 years of relevant experience required.

Nice To Haves

Experience with electronic document and quality management systems, including MasterControl and Veeva.

Responsibilities

Archive, organize, and maintain controlled documents and records in compliance with quality and regulatory requirements.
Coordinate the shipment, tracking, storage, and retrieval of documents sent to off-site archival facilities.
Prepare, verify, and package-controlled documents for off-site archival storage, ensuring accuracy, completeness, and compliance with document retention procedures.
Create, issue, and maintain logbooks, laboratory notebooks, and batch records to support operational and quality system activities.
Manage and prioritize document-related requests through the Jira ticketing system, ensuring timely resolution and customer support.
Process, route, review, and maintain controlled documents within the MasterControl electronic document management system. Includes formatting documents, creating training courses, etc.
Ensure document accuracy, version control, and compliance with established procedures and Good Documentation Practices (GDP).
Support document lifecycle activities, including creation, revision, approval, distribution, archival, and retirement of quality system documents.
Collaborate with cross-functional departments to facilitate document control processes and maintain audit-ready records
Provide support of day-to-day operations of the Quality System department for multiple sites and support internal and external customers.
Administered and supported the MasterControl document management system, managing user access, document workflows, troubleshooting, and compliance with quality system requirements.
Assist with employee “on-boarding” training on general quality specific procedural requirements.
Participate in the internal audit program.
Create and modify user groups, training items, curricula, group trainings and assignments.
Assist with preparation of QMS metrics.
Support continuous improvement projects to enhance quality system performance and operational efficiency.
Support Quality Records, VEEVA system. Create reports, dashboards, ability to pull metrics and assist in admin type activities.