QA Specialist IV

Location: Houston, TX
Department: Quality Assurance
Reports to: Associate Director, Quality Ops, Quality Assurance 

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:

• Review and approve QC test results, laboratory records, and batch analysis documentation. 
• Investigate QC-related deviations, OOS/OOT results, and non-conformances. Participate in root-cause analysis and develop CAPA actions.
• Review, evaluate, and approve change control requests impacting QC processes or systems.
• Review and support method validation, method verification, and transfer documentation.
• Review equipment qualification records (IQ/OQ/PQ) and calibration documents.
• Conduct internal audits of QC laboratories and follow up on corrective actions.
• Assist with external audits by regulatory authorities and customers.
• Ensure data integrity and laboratory compliance with electronic systems (LIMS, ELN, etc.).
• Support disposition/ Hold/ Rejection of raw materials 
• Partner with other departments to implement, optimize, review, and approve quality control records, practices, and procedures.
• Participate in audits when needed.
• Other duties as required.

Qualifications/Skills

• Bachelor’s degree in a scientific field required.
• 5 yrs in Quality Assurance/Quality Control within the field or an equivalent combination of education and experience.
• Quality Control experience required
• Understanding of Cell and Gene Therapies.
• Understanding of cGMPs, GLPs and GXPs.
• Previous experience with LIMS systems (preferable LabVantage experience)
• 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.