QA Specialist IV
Apply NowCompany: Resilience Texas LLC
Location: Houston, TX 77084
Description:
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 six 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, 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 growing, state-of-the-art, 60,000 sq. ft. industrial facility in the Texas Medical Center is staffed by an integrated team of 94+ 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:
Qualifications:
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.
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 six 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, 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 growing, state-of-the-art, 60,000 sq. ft. industrial facility in the Texas Medical Center is staffed by an integrated team of 94+ 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:
- Perform system admin responsibilities for Veeva.
- Manage the process for the creation, review, approval, and issuance of GxP controlled site documents and records including batch records, logbooks, forms, etc.
- Manage the processing, archival, filing, scanning, indexing, and formatting of new and existing documents within guidance of the document control procedures via the document management system (Veeva Docs).
- Administer and monitor QMS training and perform as a training curriculum admin for site.
- Monitor and support implementation and execution of electronic systems, including assessment of use, needs and areas of improvement.
- Support the partnership of cross-functional departments to ensure alignment of processes, systems and procedures within Veeva, and continuous improvement and user experience within the system.
- Lead improvement initiatives working with a cross-functional team and manage the project to overcome any roadblocks to the projects completion.
- Other duties as required.
Qualifications:
- Bachelor's degree in a scientific field.
- 5+ 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.
- Strong 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.
- Able to lead projects and resolve or problem-solve areas needed.
- General knowledge in implementation and continuous improvement on electronic systems (example, Veeva, LIMS, electronic batch records, etc.) preferred.
- Demonstrate ability to be an SME for Quality Services.
- Lean Six Sigma Yellow Belt Certification preferred.
- Proficient with Microsoft Office Suite or related software.
- Able to independently lead projects.
- Able to work independently on routine tasks with minimal guidance or oversight.
- Demonstrate initiative to take on additional responsibilities.
- Able to train junior members within the department.
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.