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Document Control Specialist

Company: Repare Therapeutics Inc.
Location: Cambridge
Posted on: November 23, 2021

Job Description:

Website: About Repare Therapeutics We're 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 Pol? inhibitor programs. Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. So, if you're ready to work on scientific breakthroughs where your desire to be part of a collaborative team of scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients' lives, let's talk. About the Role Repare Therapeutics is looking for a Document Control Specialist 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 maintaining document control procedures as well as participation in the development and deployment of document control tools. What You'll Do * 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 * Provide user assistance and training on the DMS * Deliver training regarding document control processes, QA orientation, and set up of new employees into the QMS * 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, deviations, CAPA follow-up, and logs contemporaneously * Assist with generating Quality Document Control metrics, as needed * Assist Quality Management by performing various tasks in support of the administration and maintenance of Quality Systems What You'll Need * Bachelor's degree * Highly Proficient in Word, Excel, and PowerPoint * Must be computer savvy with the capability to learn new systems * Knowledge of Smartsheet and SharePoint are a plus * Highly organized and ability to multitask in a fast-paced environment * Worked in an FDA regulated environment is a plus * Proficient in document management systems * Strong interpersonal and communication skills * Ability to organize and prioritize work * Strong written and verbal communication skills * Ability to review others documentation to spot any errors * Any QA document control experience a plus We are committed to building an inclusive culture of belonging that not only embraces the diversity of our people but also reflects the diversity of the communities in which we work and those that we serve. We know that the happiest and highest performing teams include people with diverse perspectives and ways of solving problems, so we strive to attract and retain talent from all backgrounds and create workplaces where everyone feels empowered to bring their full, authentic selves to work. Repare Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Keywords: Repare Therapeutics Inc., Cambridge , Document Control Specialist, Other , Cambridge, Massachusetts

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