Senior Research Quality Analyst - Human Genome Sequencing Center - Clia Lab

Baylor College of Medicine

Houston, TX

Job posting number: #7077454 (Ref:6676-en_US)

Posted: April 19, 2021

Application Deadline: Open Until Filled

Job Description

Summary

The Senior Research Quality Analyst position in the Human Genome Sequencing Center's (HGSC) will apply expertise in the area of Quality and Compliance Management.  This position will conduct various quality management projects and to maintain laboratory compliance with FDA’s Good Laboratory Practices (GLP), Good Clinical Practice (GCP), CAP/CLIA, as well as State and Federal regulations. This position is essential to continue COVID testing/research and clinical sequencing projects and to maintain laboratory compliance. These projects are highly visible and impact the national reputation of the HGSC and of Baylor College of Medicine. 

 

The Senior Research Quality Analyst position in the Human Genome Sequencing Center's (HGSC) will apply expertise in the area of Quality and Compliance Management.  This position will conduct various quality management projects and to maintain laboratory compliance with FDA’s Good Laboratory Practices (GLP), Good Clinical Practice (GCP), CAP/CLIA, as well as State and Federal regulations.
 

 

Position is located at the main BCM Campus in the Texas Medical Center.

 

Current BCM employees who are eligible to transfer are encouraged to apply.

Job Duties

• Develops and maintains standard operating procedures and provide training in newly developed standard operating procedures.
• Maintains functional Quality Control programs including but not limited to equipment qualifications/validations, process validation, ensuring preventive maintenance schedules are maintained and perform internal quality audits.
• Maintains meeting minutes for Quality Management Committee and Process Improvement meetings.
• Maintains records of testing personnel to include education, license or certifications, technical training, in service training, competency testing and testing experience.
• Maintains records and data associated with contract clinical trials.
• Coordinates continued education sessions for residents, post-doctoral fellows and laboratory personnel.
• Performs routine study audit and lab inspection to ensure adherence to laboratory procedures and policies and conduct procedures in compliance with all relevant guidelines in accordance with good laboratory practices regulations.

Minimum Qualifications

  • Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
  • Five years of relevant experience.

Preferred Qualifications

  • Experience directly related to GLP, GCP, CAP/CLIA regulations and Quality Systems.
  • Essentials in a clinical laboratory and clinical trials. 

 

 

 

 

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

 6676

CA; CH 



Baylor College of Medicine fosters diversity among its students, trainees, faculty and staff as a prerequisite to accomplishing our institutional mission, and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care. - Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective. - Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve. - Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.


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