QA Specialist III

Resilience Texas LLC•Houston, TX

About The Position

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.

Requirements

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.

Responsibilities

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.

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