Senior Clinical Lab Compliance Analyst

Vacancy number: 
7938
Department: 
Human Genome Sequencing Center
Salary range: 
$51,256 - $64,000
Location: 
Texas Medical Center, Houston, TX

Summary

The Human Genome Sequencing Center was founded in 1996 under the leadership of Dr. Richard Gibbs and is a world leader in genomics. The fundamental interests of the HGSC are in advancing biology and genetics by improved genome technologies. As one of the three large-scale sequencing centers funded by the National Institutes of Health, the HGSC provides a unique opportunity to work on the cutting-edge of genomic science in a state of the art institution.

Today, the HGSC is comprised of more than 160 Faculty, Staff and Students, and it occupies more than 36,000 square feet on the 14th, 15th, and 16th floors of the Margaret M. and Albert B. Alkek Building. The HGSC is located on the southwest edge of downtown Houston, the fourth largest city in the U.S., in the Texas Medical Center, the world's largest medical complex. The major activity of the HGSC is high-throughput DNA sequence generation and the accompanying analysis. The HGSC is also involved in developing the next generation of DNA sequencing and bioinformatics technologies that will allow greater scientific advances in the future.

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 clinical sequencing projects and to maintain laboratory compliance. Provides technical assistance to the Quality and Compliance Manager to 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.

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

  • Master's degree in a Basic Science or related field and three years of directly related experience will also be considered.
  • At least five years of work experience directly related to GLP, GCP, CAP/CLIA regulations and Quality System Essentials in a clinical laboratory and clinical trials.
  • Strong organizational skills.
  • Familiarity with document control.

 

 

 

 

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