Intern, Quality Assurance Document Control

Location: Houston, TX (Onsite)
Department: Quality Assurance
Reports to:  Associate Director, Compliance and Quality System 

 About CTMC 

CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, located in the heart of the Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.     

Since inception in May 2022, our team has filed eight INDs and have received approval, without delay, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.     

Our growing, state-of-the-art, 60,000 sq. ft. industrial facility in the Texas Medical Center is staffed by an integrated team of industry veterans and academic scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our organizational goals.     

At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure to inspire professional growth and satisfaction. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission to accelerate cell therapies from bench to bedside for patients who need them. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission.   

 
Responsibilities 

• Process controlled document requests, including creation, revision, approval, issuance, and archival.
  • Issuance of controlled documents for manufacturing operations.
  • Receive, review, and log incoming documentation (SOPs, batch records, protocols, specifications)
• Check in/out controlled documents, ensuring proper version control, and revision history.
• Scan and archive hardcopy documents into the electronic document management system. 
• Maintain filing systems for physical records, including off-site archives. 
  • Perform routine checks on document repositories to identify missing or misfiled records.
• Maintain document logs, indices, and archival storage systems. 
• Maintain the integrity of the Document Management System (paper-based).
  • Control access and distribution of documents to authorized personnel only.
• Ensure documents are formatted according to company standards and comply with cGMP requirements.
• Provide basic troubleshooting and user support for document management software. 
• Other duties as assigned.  

Qualifications/Skills 

• High School Diploma required, enrollment in a minimum Bachelor’s degree program in a relevant field preferred or enrollment in a specialized Cell Therapy or biotech degree program.
• Previous laboratory experience preferred.
• Able to learn testing procedures and work utilizing standard operating procedures.
• Able to work in a fast-paced environment.
• Demonstrated ability to be nimble, collaborative, and eager to contribute.
• Good communication skills.
• Proficient with MS Office (Excel, Outlook, etc.).

Working Conditions, Equipment, Physical Demands  

The incumbent in this position works in an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands:  

Equipment- 

• Computer, printer, fax, telephone, and laboratory testing equipment

Physical Demands-  

• Occasional standing and walking required
• Frequent sitting, reaching, and computer/keyboard usage
• Occasional lifting, pushing, and pulling up to 10lbs.required

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.  

The above job description is an overview of the functions and requirements for this position.  This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.