The Research and Development team at Foundation Medicine is constantly pushing the envelope to transform cancer care.
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About the Job
The Project & Document Control Specialist supports the Assay Development Team responsible for developing advanced genomics platforms and assays that power the future of oncology testing. This role provides traditional project coordination support, document management and quality systems expertise to an interdisciplinary team focused on deploying high-impact, complex clinical assays at large production scale. This position contributes to many of the projects undertaken in Assay Development efforts with a direct impact on patient care.
• Track project deliverables, schedules and team assignments across all projects within the group.
• Track and process all Assay Development program quality documents, including:
· Design History Files;
· Operating Procedures;
· Materials and Reagent Specifications; and,
· Process and Equipment Validations.
• Coordinate document changes, revisions, and facilitate document approvals.
• Document meeting discussions and decisions into meeting minutes.
• Serve as primary liaison to the Quality Assurance and Document Control organizations for the Assay Development group.
• Assist in all aspects of the full operation, implementation, and maintenance of the electronic document management system for controlled issue, retrieval, archiving of CLIA, CAP, and FDA regulated documents to support site operations.
• Support timely completion of key Assay Development projects by working closely with multiple project leads to ensure proper setup and execution of document workflows.
• Research new ways to improve current business and system processes.
• Implement new processes to streamline current business and system practices to FDA compliance.
• Maintain point-of-contact availability for meetings on department projects and programs, and present to stakeholders on project status.
• Serve as the Assay Development group’s “go-to” expert on document version control management.
• Manage short term duration projects as assigned.
• Provide general assistance to the program and project team(s) as needed.
• Other duties as assigned.
• Bachelor’s Degree and 1+ year of experience in Document Control, Quality Assurance, or Regulatory Compliance positions; OR,
• High School or Technical School Diploma and 5+ years of relevant experience
• Previous Document Control or Record Management experience
• Experience with Master Control® system
• Experience with resource and project tracking processes and tools
• Experience working with or in a laboratory environment or the pharmaceutical industry
• Proficiency in Word, Excel, and PowerPoint
• Exposure to and knowledge of regulatory compliance including CLIA, CAP, FDA-QSR, ISO, GMP, GCP, and 21 CFR Part 11 compliance
• Familiarity with clinical laboratory and/or medical device technologies and quality systems
• Ability to work both independently and in a team in a fast-paced, dynamic and results-oriented environment
• Ability to effectively communicate, both written and verbally, across multiple teams
• Detail oriented with excellent prioritization and organizational skills
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to FMI’s values: passion, patients, innovation and collaboration
Internal applicants, please use your FMI email address.