Research Quality Analyst

Job Purpose

Provides technical assistance to the Senior Quality Assurance Analyst (Research) 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. Assists the development of procedures including validating and training in these procedures. Assists in training sessions related to the needs of the program.

Job Duties

• Assists in developing and maintaining 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 adherance to laboratory procedures and policies and conduct procedures in compliance with all relevant guidelines in accordance with good laboratory practices regulations.
• Performs quality control testing; establishes, performs, and interprets other quality control testing related to activities of program.
• Assists in maintenance of quality assurance/quality control program; performs equipment qualification and validation; ensures that preventative maintenance schedules for all equipment are established and maintained; performs process validation related to all procedures in the program; performs internal quality audits.
• Assists in the development and maintenance of standard operating procedures; develops standard operating procedures for all activities within the program; ensures that these procedures meet or exceed all relevant state and federal requirements for handling of biological and cellular components and products; updates procedures according to changes in clinical or laboratory practice or regulations.

Minimum Qualifications

• Bachelor's degree in a basic science or related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

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

4725

CH