Sr. Nonconformance Specialist

Foundation Medicine-posted 2 days ago
Full-time • Mid Level
Onsite
251-500 employees
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The Nonconformance Specialist is responsible for overseeing the identification, documentation, investigation, and resolution of nonconformances within Foundation Medicine’s QA LabOps Team. This role ensures that all nonconformance events are managed in compliance with regulatory standards and internal policies, driving continuous improvement and supporting a culture of quality and accountability. The Nonconformance Specialist collaborates with laboratory staff, quality assurance professionals, and management to ensure timely and effective corrective and preventive actions (CAPA) are escalated when required and Nonconformances (NCR) are closed on time. This position supports the execution of multiple projects and is accountable for achieving related business goals.

  • Drives and oversees all nonconformance management activities to ensure compliance with applicable regulatory agencies and internal standards, including organizing, facilitating, and participating in investigations and resolution processes.
  • Monitor trends and provide data to leadership.
  • Inform department leadership of unfavorable trends before they result in noncompliance.
  • Track phase turnaround time for all nonconformances.
  • Lead and develop trainings on root cause analysis and nonconformance process.
  • Coordinate root cause, investigation, and phase overdue meetings with stakeholders.
  • Maintain complete and accurate records of nonconformance events, ongoing documentation for audits, and tracking corrective actions to resolution.
  • Establish internal nonconformance management processes and ensure proper documentation and training.
  • Manage the triage of new nonconformances and ensures proper assignment to the correct QA Approver.
  • Promote internal and external customer satisfaction and a culture of service excellence by meeting the customer’s quality expectations.
  • Provide detailed reports to the Sr. Director on feedback and suggestions on the Veeva NCR system.
  • Conduct root cause analysis and implementation of correction, corrective and preventive actions, and verification of effectiveness as required.
  • Provide training and mentorship to less experienced members of QA staff across the QA organization.
  • Ensure the work climate/culture within Quality System exemplifies our Company's Leadership behaviors.
  • May assist in special projects, including site implementations and other activities as required.
  • Other duties as assigned.
  • Bachelor’s Degree or equivalent experience
  • 3+ years of experience in Nonconformance management within a regulated environment (biotech, pharma, or diagnostics)
  • 5+ years of related professional experience
  • Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international
  • Demonstrated ability to lead, communicate, interact, and influence effectively at technical levels across functions
  • Demonstrated capacity to work in a fast-paced environment with strong attention to detail
  • Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow
  • Demonstrated ability to consistently meet or exceed project deadlines
  • Demonstrated ability to maintain confidentiality of business and proprietary information
  • Demonstrated knowledge of bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standards
  • Strong collaboration skills with the ability to work with multiple stakeholders in a matrixed environment and to adjust accordingly to accommodate changing priorities
  • Strong skills in troubleshooting and problem solving
  • Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues
  • Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
  • Proficiency in relevant analytical methodology and emerging new technologies
  • Understanding of HIPAA and importance of patient data privacy
  • Commitment to reflect Foundation Medicine’s values: integrity, courage, and passion
  • Advanced degree in the sciences, engineering, business, or a related field
  • ASCP or MT(AMT) Certification
  • ASQ Certification
  • Experience supporting a CLIA, QC, and laboratory
  • Experience with next generation sequencing methodology; knowledge of molecular biology
  • Experience with IVD, or Medical Device product development, analytical validation and product approval
  • A discretionary annual bonus may be available based on individual and Company performance.
  • This position also qualifies for Foundation Medicine's benefits.
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