Sr cGMP Specialist-Quality Control Analytical Radiochemist

About the role

The Sr. cGMP Specialist - Quality Control Analytical Radiochemist position at Houston Methodist Hospital is responsible for supporting time-critical clinical release testing of short-lived PET radiopharmaceuticals, applying USP and 21 CFR Part 211/212 in QC testing, and performing radiochemical and radioanalytical testing unique to PET isotope manufacturing. This role also involves participating in Out-of-Specification (OOS) investigations, deviations, and Corrective and Preventative Action (CAPA) from a QC analytical role.

Responsibilities

• Safely handles radioactive materials in accordance with state radiation safety requirements
• Supports time critical clinical release testing of short lived PET radiopharmaceuticals
• Applies USP and 21 CFR Part 211/212 in QC testing
• Performs radiochemical and radioanalytical testing unique to PET isotope manufacturing
• Participates in OOS investigations, deviations, and CAPAs from a QC analytical role
• Works in a radiochemistry laboratory

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, determined through on-going skills, competency assessments, and performance evaluations
• Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
• Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
• Familiar with quality, compliance and FDA regulatory requirements for Good Laboratory Practice (GLP) and cGMP auditing procedures
• Proficiency in spreadsheet, word processing and presentation software
• Ability to work under pressure and balance many competing priorities; highly responsive and solution/action oriented
• 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 (GLP, Phase I, Phase II/III etc.)
• Ability to mentor and coach department personnel
• Demonstrates highly effective communication skills and the ability to lead both informal/formal educational sessions to include classroom/seminar instruction in cGMPs and specialized topics related to compliance and best practices