cGMP technician

At Houston Methodist, the cGMP Technician position is responsible for supporting and assisting the production of therapeutics and medical devices by following Standard Operating Procedures (SOPs) and learning to apply current Good Manufacturing Practices (cGMP). Under the guidance of cGMP team members, this position will assist with compliance activities, verify equipment and facility cleanliness, accurately record data into relevant systems, receive, label, and process samples. The cGMP Technician position will perform basic maintenance tasks, ensuring equipment is in good working order.

FLSA STATUS
Exempt

QUALIFICATIONS

EDUCATION

• Bachelor’s degree or four years’ experience in lieu of a bachelor's degree

EXPERIENCE

• Experience within a regulated environment (FDA, NIH, Instructional/Teaching facility) with exposure to cGMP manufacturing operations preferred

KNOWLEDGE AND ABILITIES

• Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through ongoing 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
• Basic understanding of quality, compliance, and FDA regulatory principles, with an interest in learning Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP)
• Proficiency in spreadsheet, word processing and presentation software
• Ability to work under pressure and balance many competing priorities; highly responsive and solution/action oriented
• Willingness to learn from and collaborate with experienced team members; open to feedback and coaching
• General awareness of drug and device regulations (e.g., 21 CFR Parts 210/211, ICH guidelines) with a desire to deepen knowledge and apply it appropriately across different stages of development (GLP, Phase I–III)
• Supports the preparation and delivery of pre-clinical and clinical materials in alignment with production schedules and quality expectations
• Collaborates with cross functional teams including research, process development, quality assurance and quality control

ESSENTIAL FUNCTIONS

PEOPLE ESSENTIAL FUNCTIONS

• Collaborates with all members of the cGMP team by actively communicating, providing meaningful contributions and reporting pertinent information as it relates to assigned system(s) in a comprehensive manner.
• Works with research team members to assist them with transitioning their research processes to compliant cGMP SOPs.

SERVICE ESSENTIAL FUNCTIONS

• Maintains accurate records of manufacturing processes.
• Accurately entering data into relevant systems.
• Participates in internal audits and external inspections by regulatory agencies.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

• Maintains laboratory equipment, ensuring it is in good working order, and performs basic maintenance tasks.
• 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 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.
• Supports Sr cGMP staff with ad-hoc projects as required.

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* No

TRAVEL**
**Travel specifications may vary by department**
• May require travel within the Houston Metropolitan area No
• May require travel outside Houston Metropolitan area No




Work Shift:

1 - Day (United States of America)



Job Category:

Non-clinical

Houston Methodist is one of the nation’s leading health systems and academic medical centers. The health system consists of eight hospitals: Houston Methodist Hospital, its flagship academic hospital in the Texas Medical Center, seven community hospitals and one long-term acute care hospital throughout the Greater Houston metropolitan area. Houston Methodist also includes a research institute; a comprehensive residency program; international patient services; freestanding comprehensive care clinics, emergency care and imaging centers; and outpatient facilities. Come lead with us!


Houston Methodist is an Equal Opportunity Employer.