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.

FLSA STATUS

Exempt

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, 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

ESSENTIAL FUNCTIONS

PEOPLE ESSENTIAL FUNCTIONS

• 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

SERVICE ESSENTIAL FUNCTIONS

• 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 subject matter expert in support of department functions.

• Reviews testing documentation from all cross-functional departments

QUALITY/SAFETY ESSENTIAL FUNCTIONS

• Ensures development, pre-clinical and clinical product supply are executed effectively against changing demand schedule and meet quality requirements.

• Conducts internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and cGMP Core policies and procedures.

FINANCE ESSENTIAL FUNCTIONS

• Uses resources efficiently; does not waste supplies. Self-motivated to independently manage time effectively and prioritize daily tasks

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

• Participates with the Quality Assurance Manager and/or cGMP Core Director in defining quality policies.

• Assists Quality Assurance Manager, cGMP Core Director and/or team members in defining release testing requirements, developing and executing protocols, performing periodic updates and/or revisions to SOPs.

• Interfaces with core users to assist in the translation of research processes to the cGMP manufacturing facility.

• Seeks opportunities to expand learning beyond baseline competencies with a focus on continual development.

• Identifies opportunities for improvement and leads projects which result in innovative solutions that increase the level of compliance and efficiency of the team.

SUPPLEMENTAL REQUIREMENTS

WORK ATTIRE

• Uniform: No

• Scrubs: No

• Business professional: Yes

• Other (department approved): No

ON-CALL*

*Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below.

• On Call* Yes

TRAVEL**

Travel specifications may vary by department

• May require travel within the Houston Metropolitan area No

• May require travel outside Houston Metropolitan area No

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

Company Profile:

Houston Methodist Academic Institute oversees the Education Institute and Research Institute. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports clinical research protocols and extramurally funded translational research programs.

Houston Methodist is an Equal Opportunity Employer.