About the Job

The Senior Specialist, Quality Assurance Laboratory Operations leverages skill in efficient, regulation-adherent processes, 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 making recommendations to improve the quality of processes and products. The Senior Specialist ensures continued compliance with CLIA, NYS DOH, and other applicable regulations.

Key Responsibilities

• Assist in all aspects of the full operation, implementation, and maintenance of the Quality Management System (QMS) to ensure continued compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA), College of American Pathologists (CAP), and the FDA.
• Review and approve the information to ensure it meets FMI standards and procedures and is clearly and appropriately justified as applicable, including but not limited to:
  • Non-Conformance reports;
  • Deviation Investigations;
  • Corrective Action Preventative Action reports;
  • Quality Control records;
  • Process Improvement.
• Maintain availability to the wider FMI business to consult and provide guidance on Good Practice (GxP) quality guidelines and specific regulations, including but not limited to:
  • Clinical Laboratory Improvement Amendments of 1988 (CLIA);
  • College of American Pathologists accreditation standards;
  • Good Clinical Practice (GCP);
  • 21 CFR Part 11 compliance;
  • Food and Drug Administration and FDA Good Manufacturing Process;
  • Laboratory state regulations including Massachusetts, North Carolina, California, and New York.
• Trigger risk assessment process as required per established regulations or procedures and coordinate and lead analyses.
• Provide departmental training as needed as part of Site New Employee Onboarding Training.
• Actively communicate with the various areas and departments to identify areas of improvement.
• Seek new ways to improve current business and system processes and, in collaboration with the Sr. Specialist, work with department leaders to implement improvements.
• Assist with implementation of new processes to streamline current business and system practices to regulatory compliance with key stakeholders and department leaders.
• Create, review, and approve documents including Standard Operating Procedures, Quality Metrics Reports, Annual Product Reviews, and other documents, as needed.
• Coordinate audit responses process as it pertains to laboratory findings.
• Maintain organization and attention to detail in a fast-paced workflow environment.
• Assist with internal and external audits as necessary.
• Lead or support FDA, NTS DOH, CAP, and other regulatory agency inspections for backroom support/document retrieval as needed.
• Provide support and contribute to other QA activities as needed.
• Participate in projects associated with Quality activities as needed.
• Work and interact cross-functionally with a wide variety of people and teams to foster a solution-focused approach to opportunities.
• Approve incoming materials.
• Travel domestically up to 5% of the time.
• Other duties as assigned.

Qualifications:

Basic Qualifications:

• 0-3 years of prior experience with patient testing laboratory quality
• Bachelors in Science
• Alternatively, an Associate's degree in laboratory science or related field with 5+ years of experience in clinical laboratory

Preferred Qualifications:

• Bachelor’s Degree in science or a related field
• ASQ certification or ASCP/AMT Certification
• 5+ years of experience in the pharmaceutical, biotechnology, medical device, diagnostics, or clinical laboratory industries
• Prior experience working in a QA environment
• Working knowledge of applicable business systems including: MasterControl, Maximo, LIMS, and Smartsheet
• Exposure to regulatory compliance knowledge including ISO 13485, ISO 15189, CLIA, CAP, NYS, state requirements, GxP, and 21 CFR Part 11 Compliance
• Ability to multitask within specified timelines
• Ability to work well under pressure while maintaining a professional demeanor
• Detail-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 reflect FMI’s values: Integrity, Courage, Passion

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