Senior QA Specialist, Laboratory Operations

Foundation Medicine•Morrisville, NC

8d•Onsite

About The Position

The Senior Specialist, Quality Assurance Laboratory Operations supports efficient, regulation-adherent quality processes and improvements across laboratory operations. The role is responsible for inspections, monitoring, auditing, maintaining quality standards in response to regulatory and procedural changes, and recommending improvements to the quality of processes and products. It helps ensure continued compliance with CLIA, NYS DOH, and other applicable regulations. The position supports implementation and maintenance of the Quality Management System (QMS), reviews and approves quality records and documents, provides guidance on GxP quality requirements, coordinates risk assessments and audit responses, and contributes to internal and external audits and regulatory inspections. It also supports training, process improvements, incoming-material approvals, and cross-functional quality projects. Domestic travel is required up to 5% of the time. The position is based in Morrisville, North Carolina, and is identified as onsite.

Requirements

0–3 years of prior experience with patient-testing laboratory quality, with a bachelor's degree in science; alternatively, an associate degree in laboratory science or a related field and 5+ years of experience in a clinical laboratory.
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, including written and oral communication, collaboration, 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, ASCP, or 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 operation, implementation, and maintenance of the QMS to support 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 guidance to FMI teams on GxP quality guidelines and applicable regulations, including CLIA, CAP standards, GCP, 21 CFR Part 11, FDA requirements, and state laboratory regulations.
Trigger, coordinate, and lead risk assessments as required by regulations or procedures.
Provide departmental training as needed, including as part of Site New Employee Onboarding Training.
Communicate with departments to identify improvement opportunities and collaborate with the Sr. Specialist and department leaders to implement improvements.
Assist with implementation of 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 audit responses related to laboratory findings.
Assist with internal and external audits.
Lead or support regulatory agency inspections, including FDA, NYS DOH, and CAP inspections, providing backroom support and document retrieval as needed.
Provide support for other QA activities and participate in quality-related projects as needed.
Work cross-functionally to foster a solution-focused approach to opportunities.
Approve incoming materials.
Travel domestically up to 5% of the time.
Comply with FMI attendance policies and perform other duties as assigned.