cGMP Specialist - Quality Control

The CGMP Specialist, Quality Control is responsible for establishing and executing GLP- and GMP-compliant analytical methods to support the characterization, release, and stability testing of nucleic acid and nanoparticle products. This role provides analytical expertise for QC method development, transfer, validation, and routine testing activities, ensuring data integrity, regulatory compliance, and product quality. Under the guidance of the Quality Manager, the individual authors and reviews GMP documentation, investigates analytical deviations and out-of-specification results, and supports regulatory inspections, audits, and client interactions. In addition, the CGMP Specialist serves as a technical trainer for laboratory personnel and contributes to a culture of quality, continuous improvement, and inspection readiness.

The cGMP Specialist I / Production is expected to achieve proficiency on processes and manufacturing procedures related to clinical products under specific projects, in order to assure that the products have the safety, identity, strength, quality, and purity that it purports or is represented to possess for our patients and customers.

As a member of the Office of Translational Production & Quality, this position will actively participate in continuous quality improvement initiatives, pursue continuing education opportunities and work within the cGMP and cGTP guidelines, following regulatory standards such as FACT, CAP and AABB, as applicable.

At Houston Methodist, the Current Good Manufacturing Practice (cGMP) Specialist position 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 assisting senior team members with 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.

FLSA STATUS

Exempt

QUALIFICATIONS

EDUCATION

• Bachelor’s degree

• Master’s degree preferred

EXPERIENCE

• Three years of experience in the biotechnology or pharmaceutical industry 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

• Ability to mentor and coach department personnel

• 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.)

ESSENTIAL FUNCTIONS

PEOPLE ESSENTIAL FUNCTIONS

• 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 SOPs.

• Participates in multi-functional project teams, as necessary.

SERVICE ESSENTIAL FUNCTIONS

• Participates in internal audits and external inspections by Regulatory Agencies.

• Responds to calls/alarms off hours and weekends for facility systems and equipment failures.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

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

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

• Assists with discrepancy inspections.

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

• 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.

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

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’s degree

• Master’s degree preferred

EXPERIENCE

• Three years of experience in the biotechnology or pharmaceutical industry 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.