Sr Quality Assurance Specialist

Baylor Genetics
Houston, Texas, United States
Full Time
On Site
Senior
0+
Bachelor Degree
Healthcare Healthcare Life Sciences

Posted 1 month ago

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Excellent 4.7

Job summary

The Senior QA Specialist is a subject matter expert managing quality processes, investigating quality events, leading audits, analyzing data, and ensuring compliance in a clinical laboratory setting.

Responsibilities

The Senior QA Specialist serves as a subject matter expert to identify systemic quality risks and translate data into actionable improvements. They lead complex cross-functional investigations, manage CAPA processes, and ensure regulatory compliance across laboratory operations.

Qualifications

Auditing CAPA (Corrective and Preventive Actions) Data Analysis Laboratory Testing Quality Data Reporting Quality Management System Regulatory Compliance Regulatory Standards (CLIA, CAP, FDA, NYS) Root Cause Analysis SOP Writing and Review

Candidates must hold a Master's degree with 3 years of experience or a Bachelor's degree with 6 years of experience in a clinical laboratory setting. Proficiency in quality management principles, regulatory standards like CLIA/CAP/FDA, and root cause analysis methodologies is required.

English

Company

Baylor Genetics

Baylor Genetics

linkedin
Biotechnology Research
Location
Houston, Texas, United States

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Excellent 4.7
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