Senior QA Specialist, Laboratory Operations
About The Position
The Senior Specialist, Quality Assurance Laboratory Operations uses expertise in efficient, regulation-adherent processes, assessments, and process improvements to enhance quality functions, procedures, operations, and systems. The role prioritizes inspections, monitoring, auditing, revising quality standards in response to regulatory and business procedural changes, and recommending improvements to the quality of processes and products. It ensures continued compliance with CLIA, NYS DOH, and other applicable regulations. The position supports the operation, implementation, and maintenance of the Quality Management System (QMS), reviews and approves quality records and documents, provides guidance on GxP quality guidelines and regulations, coordinates risk assessments and audit responses, and supports regulatory inspections. It works cross-functionally to identify and implement process improvements, provides departmental training as needed, approves incoming materials, and contributes to other quality projects and activities. Domestic travel of up to 5% is required.
Requirements
- 0–3 years of prior experience with patient-testing laboratory quality.
- Bachelor’s degree in science, or alternatively an associate degree in laboratory science or a related field with 5+ years of clinical laboratory experience.
- Ability to multitask within specified timelines.
- Ability to work well under pressure while maintaining a professional demeanor.
- Detail-oriented, with strong prioritization and organizational skills.
- Strong written and oral communication, collaboration, interpersonal, and problem-solving skills.
- Understanding of HIPAA and the importance of patient data privacy.
- Commitment to reflect FMI’s values of Integrity, Courage, and Passion.
Nice To Haves
- 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 MasterControl, Maximo, LIMS, and Smartsheet.
- Exposure to regulatory compliance requirements including ISO 13485, ISO 15189, CLIA, CAP, NYS and other state requirements, GxP, and 21 CFR Part 11.
Responsibilities
- Assist with the operation, implementation, and maintenance of the Quality Management System to ensure compliance with CLIA, CAP, and FDA requirements.
- Review and approve non-conformance reports, deviation investigations, corrective and preventive action reports, quality control records, and process improvement documentation.
- Provide consultation and guidance on GxP quality guidelines and applicable regulations, including CLIA, CAP, GCP, 21 CFR Part 11, FDA requirements, and laboratory state regulations.
- Initiate risk assessments as required and coordinate and lead analyses.
- Provide departmental training as needed, including Site New Employee Onboarding Training.
- Communicate with departments to identify opportunities for improvement.
- Work with the Sr. Specialist and department leaders to identify and implement improvements to business and system processes.
- Support implementation of new processes that streamline business and system practices while maintaining regulatory compliance.
- Create, review, and approve standard operating procedures, quality metrics reports, annual product reviews, and other documents as needed.
- Coordinate responses to laboratory audit 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, NYS DOH, CAP, and other regulatory agency inspections, including backroom support and document retrieval as needed.
- Provide support for other QA activities and participate in quality-related projects as needed.
- Work cross-functionally with a variety of people and teams to foster a solution-focused approach.
- Approve incoming materials.
- Travel domestically up to 5% of the time.
- Perform other duties as assigned and comply with FMI attendance policies.
Benefits
- Foundation Medicine benefits.
- A discretionary annual bonus may be available based on individual and Company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
