Senior QA Specialist, Laboratory Operations

Foundation Medicine; Clegg (NC); On-site; USD 103,000 - 120,000; Full time

Job summary

Foundation Medicine in Morrisville, NC is seeking a Senior Specialist, Quality Assurance Laboratory Operations to oversee QA activities under CLIA, CAP, and FDA guidelines, driving process improvements and maintaining compliance. The role supports the Quality Management System, reviews documentation, coordinates audits, and collaborates across functions to implement regulatory-ready processes.

A science degree and 0–3 years in patient-testing QA are preferred; certifications are a plus.

Qualifications

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

Responsibilities

• Maintain QA system to ensure CLIA/CAP/FDA compliance.
• Review and approve information to FMI standards and procedures.
• Coordinate audits and respond to findings.
• Provide training on GxP guidelines.
• Lead or support inspections and regulatory audits.

Skills

Regulatory compliance

GxP knowledge

Quality Assurance

Education

Bachelor's degree in Science

Associate's degree in laboratory science

Tools

MasterControl

LIMS

Smartsheet

Maximo

Job description

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.


• Comply with FMI's attendance policies

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 the importance of patient data privacy


• Commitment to reflect FMI's values: Integrity, Courage, and Passion

The expected salary range for this position based on the primary location of Morrisville, NC is $103,000 - $120,000 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.

#LI-Onsite