Sr QA Associate

About The JobThe Senior Quality Assurance Associate leverages skill in efficient, regulation-adherent processes, assessments, and process improvements to further improve quality functions, formalized procedures, operations and systems. The Senior Associate 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.Key Responsibilities• Maintain periodic review compliance by communicating and following up with document owners.• Maintain quality document lifecycle through scanning, storing, and archiving in accordance with the FMI QMS.• Responsible for working and interacting cross-functionally with a wide variety of people and teams to foster a solution-focused approach to opportunities.• Ensure that records are kept under CLIA, CAP, NYS, and CA requirements such as attributable, , legible, original, contemporaneous, and accurate.• Review all Quality documents for clarity and alignment within operations.• Ensure that equipment standards are tested, calibrated, and standardized before patient testing.• Assist with Lot to Lot validations of new reagents.• May assist with nonconformance investigation and root cause analysis.• May assist with incoming material review.• May assist teams on internal audits.• Other duties as assigned.QualificationsBasic Qualifications:• HS diploma or GED equivalent• 3+ years of work experience in a clinical laboratory or quality environment.Preferred Qualifications• 5+ years of QA experience• ASCP or AMT clinical laboratory scientist certification• Excellent attention to detail and multitasking skills• Familiarity with MA & NYS regulations, CAP, and CLIA• Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem-solving with departments and colleagues• Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow• Demonstrated ability to consistently meet or exceed project deadlines• Understanding of HIPAA and the importance of privacy of patient data• Ability to work well under pressure while maintaining a professional demeanor