Lab QA/QC Specialist

SUMMARY:

The QA/QC Specialist manages all QA/QC activities in Laboratory Operations and ensures standardization across all departments.

QUALIFICATIONS:

· Education:

o BS in Biology, Biochemistry, Biotechnology Engineering or other related field required; MS preferred

· Experience:

o 2+ years of clinical laboratory experience

· Certifications preferred: MB(ASCP) or MT(ASCP) or CG(ASCP)

· Excellent verbal and written communication skills

· Demonstrated knowledge of CAP/CLIA and good laboratory practice

· Ability to create meaningful presentations

· Strong problem solving skills and root cause analysis experience

DUTIES AND RESPONSIBILITIES:

· Standardizes and maintains Reagents tracking and maintenance across all labs/departments according to the regulatory requirements.

· Assists with standard policies and procedures development and implementation.

· Oversees and ensures proper Quality Control processes has been implemented and maintained.

· Tracks test transfers from R&D to Clinical laboratory to ensure test Validations/Verification has been completed according to the regulatory requirements, checklist and report to QM.

· Participates in CAPA investigation, test troubleshooting and modifies existing protocols in order to resolve problems related to Quality Control and Quality Assurance.

· Participates in LIMS changes, implementation and validation.

· Assists with the regulatory inspections and supports Quality Management System.

· Assists with metrics development and maintenance. Troubleshoots metrics not meeting goals.

· Performs clinical lab testing on samples as assigned if needed.

· Adheres to Code of Conduct as outlined in the Baylor Genetics Compliance Program.

· Performs other job-related duties as assigned.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

· Frequently required to sit

· Frequently required to stand

· Frequently required to utilize hand and finger dexterity

· Frequently required to talk or hear

· Frequently required utilize visual acuity to operate equipment, read technical information, and/or use keyboard

· Occasionally exposure to bloodborne and airborne pathogens or infectious materials

EEO Statement:

Baylor Genetics is proud to be an equal opportunity employer dedicated to building an inclusive and diverse workforce. We do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, gender identity, veteran status, disability, genetic information, pregnancy, childbirth, or related medical conditions, or any other status protected under applicable federal, state, or local law.

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