QA Specialist III

About CTMC

CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, and located in the renowned 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, ETC, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.

In our first year alone, we have filed four INDs, each ahead of schedule, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in two years, enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.

Our state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of 94+ industry veterans and 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 mission.

At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission. 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 (The responsibilities listed are specified as but not limited to):

• Perform line-clearance/ change-over activities.
• Disposition/ Hold/ Rejection of raw materials, starting material and in-house prepared materials.
• Generate and reconcile in-process and Drug Product labels.
• Review and approve executed documents related to manufacturing operations, QC and other departments.
• Initiate deviations, CAPAs and Change Controls associated with Quality Operations practices.
• Create procedures and practices within Quality Operations to implement quality standards.
• Partner with other departments to implement and optimize batch records and procedures.
• Other duties as required.

Qualifications/Skills

• Bachelor’s degree in a scientific field.
• 3+ yrs experience in a related field, preferably QA or equivalent combination of education and experience.
• Understanding of Cell and Gene Therapies.
• Understanding of cGMPs, GLPs and GXPs.
• Knowledge of local and global regulations.
• Verbal and written communication skills.
• Interpersonal and customer service skills.
• Organizational skills and attention to detail.
• Time management skills with a proven ability to meet deadlines.
• Analytical and problem-solving skills.
• Proficient with Microsoft Office Suite or related software.

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, and telephone.

Physical Demands- Prolonged periods of sitting at a desk and working on a computer and must be able to lift up to 15 pounds at times. In addition, ability to sterile-gown and perform activities in the manufacturing suite as well as raw material area when applicable.

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.