Sr cGMP Specialist-QA/Documentation Specialist
Location
Houston, TX
Job Type
Full-time
Category
other-general
Posted
June 17, 2026
At Houston Methodist, the Sr. Current Good Manufacturing Practices (cGMP) Specialist is responsible for adherence to Standard Operating Procedures (SOPs) and cGMP regulations pertaining to the manufacture of therapeutics and devices. Additionally, this position will be responsible for all aspects of:
• QA documentation ownership for cyclotron PET radiopharmaceutical cGMP operations
• Lifecycle management of SOPs, master batch records, and controlled forms
• QA review of executed batch records (paper/electronic) for accuracy, completeness, and GDP compliance
• Application of GDP and FDA data integrity principles; resolution of documentation discrepancies
• Document control and inspection readiness support, including record organization and retrieval
• QC collaboration and documentation/QA cross coverage as needed
At Houston Methodist, the Sr. Current Good Manufacturing Practices (cGMP) Specialist is responsible for adherence to Standard Operating Proced...
• QA documentation ownership for cyclotron PET radiopharmaceutical cGMP operations
• Lifecycle management of SOPs, master batch records, and controlled forms
• QA review of executed batch records (paper/electronic) for accuracy, completeness, and GDP compliance
• Application of GDP and FDA data integrity principles; resolution of documentation discrepancies
• Document control and inspection readiness support, including record organization and retrieval
• QC collaboration and documentation/QA cross coverage as needed
At Houston Methodist, the Sr. Current Good Manufacturing Practices (cGMP) Specialist is responsible for adherence to Standard Operating Proced...