Senior QA Specialist, Laboratory Operations

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 CLIA, CAP, and the FDA.
• Review and approve information including Non-Conformance reports, Deviation Investigations, Corrective Action Preventative Action reports, Quality Control records, and Process Improvement.
• Consult and provide guidance on GxP quality guidelines and specific regulations including CLIA, CAP accreditation standards, GCP, 21 CFR Part 11, FDA and FDA Good Manufacturing Process, and laboratory state regulations.
• Trigger risk assessment process as required and coordinate and lead analyses.
• Provide departmental training as part of Site New Employee Onboarding Training.
• Communicate with various areas and departments to identify areas of improvement.
• Seek new ways to improve current business and system processes and work with department leaders to implement improvements.
• Assist with implementation of new processes to streamline business and system practices to regulatory compliance.
• Create, review, and approve documents including Standard Operating Procedures, Quality Metrics Reports, and Annual Product Reviews.
• Coordinate audit responses process as it pertains to laboratory findings.
• Assist with internal and external audits as necessary.
• Lead or support FDA, NYS DOH, CAP, and other regulatory agency inspections for backroom support/document retrieval.
• Provide support and contribute to other QA activities as needed.
• Participate in projects associated with Quality activities.
• Work and interact cross-functionally to foster a solution-focused approach.
• Approve incoming materials.
• Travel domestically up to 5% of the time.
• Other duties as assigned.
• Comply with FMI's attendance policies.

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 including written and oral communication, collaboration, and problem solving
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI's values: Integrity, Courage, and Passion