Senior Research Quality Analyst

$63,052 - $74,178/Yr

Baylor College of Medicine - Houston, TX

Full-time - Mid Level

Houston, TX

Educational Services

About the position

The Senior Research Quality Analyst will manage and coordinate the logistics operations related to safety testing of investigational new drugs for patient treatments. This role ensures compliance with FDA, IRB, FACT, and ISCT directives while performing environmental monitoring of manufacturing facilities and in-house safety testing. The position involves maintaining quality assurance programs and providing leadership and training to junior staff.

Responsibilities

• Develops and maintains standard operating procedures.
• Maintains the QA/QC program including equipment qualifications/validations and process validation.
• Provides leadership, guidance, and training to junior staff.
• Performs quality control testing following standard operating procedures.
• Maintains accurate and complete documentation of work performed.
• Conducts procedures in compliance with all relevant guidelines according to good laboratory practices regulations.
• Interprets results as designated by protocols to determine safety related to the QA/QC Program activities.
• Participates in general laboratory duties including specimen handling, records management, and supply inventory.
• Manages domestic and international shipments of clinical products to clients and hospitals for research and/or patient care.
• Handles inventory management of clinical products to comply with FDA requirements.
• Handles comprehensive maintenance and documentation of all Good Manufacturing Records.
• Is proficient in basic laboratory skills that can be expanded upon for training in current laboratory testing such as PCR and tissue culture assays.
• Has knowledge of Good Manufacturing Practices and documentation.
• Performs other job-related duties as assigned.

Requirements

• 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.

Nice-to-haves

• Master's degree in a Basic Science or a related field.
• Proficient in basic laboratory skills.