Person, Text, Face

 

Every patient sample is a story.

That's why our Lab Ops team is focused on providing physicians with comprehensive genomic information about each person's cancer. Information that's as unique as the patients are. The insights discovered in our labs may help change their story.

 

Senior Specialist, Quality Assurance Document Control

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Senior Specialist, Quality Assurance Specialist leverages their experience to lead programs, mentor their peers, develop and implement regulation-adherent processes, lead assessments and process improvements to further improve quality functions, formalized procedures, operations and systems. The Senior Specialist is responsible in order of business priority for inspections, monitoring, auditing, revising quality standards per regulation and business procedural changes, and recommendations to improve the quality of processes and products.

This is a regulated position and additional information may be available from FMI Quality Assurance regarding regulatory guidelines.

Key Responsibilities

  • Administrative leader for electronic Document Management System (eDMS)
  • Coordinate all aspects of the full operation, implementation, and maintenance of the eDMS for controlled issue, retrieval, archiving of regulated documents to support site operations.
  • Identify and Lead Implement new ways to improve current business and system processes. Implement new processes to streamline current business and system practices to regulatory compliance.
  • Responsible for maintaining, updating, and versioning of policies and procedures.
  • Perform document quality checks on all controlled documents in the eDMS
  • Coordinate the management of periodic review for required documents within the Quality Management System.
  • Assist document owners in creating documents and workflows in eDMS.
  • Maintain and oversee Quality controlled records storage.
  • Develop and maintain full inventory of storage room content.
  • Create indexing schemes based upon document and record types.
  • Implement internal procedures to ensure continued compliance of records.
  • Support implementation of corporate Records Schedule and Retention Program.
  • Serve as primary contact for all archiving issues
  • Maintain organization and attention to detail in a fast-paced workflow environment.
  • Manage all documents within the QMS according to the SOP Lifecycle Program.
  • Organize Quality Assurance documents so they are readily retrievable.
  • Lead/Support FDA and other regulatory agency inspections for backroom support/document retrieval.
  • Work with management in compiling required metrics and data for Management Review to meet regulatory requirements.
  • Provide support and contribute to other QA activities as needed.
  • Lead/Support projects associated with Document Control activities.
  • Maintain availability to work outside of regularly scheduled shift.
  • Travel domestically up to 10% of the time.
  • Other duties as assigned.

Qualifications

Basic Qualifications

  • 9+ years of experience in the medical device, diagnostics, clinical laboratory or biopharmaceutical industry – preferably in a QA environment with a HS or GED degree.
  • 4+ yrs experience in the medical device, diagnostics, clinical laboratory or biopharmaceutical industry – preferably in a QA environment with Associates degree in science or related field.

Preferred Qualifications

  • Exposure to regulatory compliance knowledge including GMP, ISO 13485, ISO 15189, CAP/CLIA, NYS, states, GCP, IVDR, and 21 CFR Part 11 Compliance
  • Previous Document Control or Record Management experience
  • Experience working with electronic document management and quality management systems highly preferred
  • Able to Lead teams and Mentor staff.
  • Ability to multitask within specified timelines
  • Ability to work well under pressure while maintaining a professional demeanor
  • Detailed oriented with excellent prioritization and organizational skills
  • Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem solving with departments and colleagues
  • Understanding of HIPAA and importance of privacy of patient data
  • Commitment to FMI values: patients, innovation, collaboration, and passion

 

About Foundation Medicine

Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

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