Position: Document Control Specialist/Manager
Company: Repare Therapeutics
Location: Cambridge, Massachusetts, USA
Website: http://www.reparerx.com/
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