Project Manager
Document Control Specialist/Manager Full-time
Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.
Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.
Repare Therapeutics is looking for a Document Control Specialist or Manager whose primary responsibility is coordinating Document Control and activities related to the identification, collection, distribution and filing of controlled documents in an FDA regulated environment. This position supports critical documentation within cross-functional teams and will ensure the integrity of document creation, version control, storage, retrieval, and lifecycle management are effectively implemented. This position will aid in ensuring that document management is consistent across the organization, while maintaining control and traceability of the documentation history in compliance with GxP regulations. Key contributions of the role will include writing, revising, and maintaining document control procedures as well as participation in the development and deployment of document control tools.
RESPONSIBILITIES
Independently manage and monitor the processing, review, and approval of all controlled documents in both electronic document management systems (DMS) and supporting manual systems
Coordinate the revision process of Standard Operating Procedures (SOPs), forms, and other controlled documents assuring that the corporate and regulatory standards are upheld
Manage the daily flow and final release of controlled documents through the document management system.
Continuous improvement of the Document Control program
Participates in the development and roll-out of document control tools, monitors documentation/Quality Systems function, and coordinates with IT on issues
Provide user assistance and training on the DMS
Develops and delivers training regarding document control processes and system changes
Ensure compliance with controlled document format and content
Maintain master documents and records (both hardcopy and/or electronic) to ensure documentation is retrievable and files are accurate, complete, and well organized
Manage the document periodic review process
Responsible for managing record retention policies and procedures
Track and communicate company training compliance within multiple departments
Assist with the development of evolving document control systems
Maintain SOP, change control, deviation, CAPA, etc. logs contemporaneously
Assist with generating Quality Document Control metrics as needed
Represent quality in departmental or team meetings
Assist Quality Management by performing various tasks in support of the administration and maintenance of Quality Systems
Represent Quality Assurance as the Subject Matter Expert (SME) for Good Documentation Practices
QUALIFICATIONS
Bachelor’s degree, Life Sciences preferred, but now required
Experience in Document Control System and network-based Quality Management Systems
Worked in an FDA regulated environment
Minimum of two (2) years QA document control experience
Proficient in document management systems
Highly Proficient in Word, Excel, and PowerPoint – Smartsheet and SharePoint are a plus
Familiar with FDA regulations
Ability to work effectively on multiple projects simultaneously with minimum supervision
Strong interpersonal and communication skills
Able to organize and prioritize work
Strong written and verbal communication skills
Effective/concise communicator with management and internal teams
Experience with working in startup environments moving in rapid growth/manufacturing