Sr cGMP Specialist-QA​/Documentation Specialist

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 Procedures (SOPs) and cGMP regulations pertaining to the manufacture of therapeutics and devices. Additionally, this position will be responsible for all aspects of compliance associated with the quality operations including, but not limited to, review of procedures, verification of equipment and facility cleanliness, proper gowning, correct material labelling, correct operating parameters for equipment and proper execution of protocols in accordance with approved SOPs and the proper guidance of junior level team members.

As a senior member of the department, this position will actively contribute to the development of policies and procedures for the delivery of novel products to our patients and customers.

Exempt

• Bachelor of Arts or Science degree
• Master’s degree preferred

• 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

• 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, PhaseII/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

• Provides work direction of authorized core users working in either production or quality control.
• Collaborates with cross-functional teams including research, process development, quality assurance and quality control.
• Works with research team members to assist them with transitioning their research processes to compliant cGMP SOP’s and participates in multi-functional project teams as necessary

• Participates in internal audits and external inspections by Regulatory Agencies and reports findings to direct management.
• Responds to calls/alarms off hours and weekends for facility systems and equipment failures.
• Serves as technical…