Sr cGMP Specialist-QA/Documentation Specialist

About the role

The Sr. Current Good Manufacturing Practices (cGMP) Specialist at Houston Methodist Academic Institute is responsible for adhering to standard operating procedures (SOPs) and cGMP regulations pertaining to the manufacture of therapeutics and devices. This position also oversees all aspects of compliance, including documentation, equipment validation, audits, and batch record reviews.

Responsibilities

• 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

Qualifications

• Education: Bachelor of Arts or Science degree, Master’s degree preferred
• Experience: Five years of biotechnology or pharmaceutical industry experience with exposure to cGMP manufacturing operations, experience performing equipment validation (IQ/OQ/PQ), facility commissioning, internal/external audits, batch record review and hosting regulatory inspections preferred

Skills and Abilities

• Demonstrates the skills and competencies necessary to safely perform the assigned job
• Sufficient proficiency in speaking, reading, and writing the English language
• Ability to effectively communicate with patients, physicians, family members and co-workers
• Familiarity with quality, compliance and FDA regulatory requirements for Good Laboratory Practice (GLP) and cGMP auditing procedures
• Proficiency in spreadsheet, word processing and presentation software
• Knowledge of regulations applicable to drugs and devices (21 CFR Parts 210/211, Medical Device Regulations, ICH and FDA guidances, etc.) and the ability to apply them based on the phase of the project
• Ability to mentor and coach department personnel
• Highly effective communication skills and the ability to lead both informal/formal educational sessions

Benefits

FLSA STATUS: Exempt

Pay

Not specified

Schedule

Not specified

Supplemental Requirements

• Work Attire: Uniform: No, Scrubs: No, Business professional: Yes, Other (department approved): No
• On-Call*: Yes
• Travel**: May require travel within the Houston Metropolitan area