Cell Therapy QA Specialist III

1 day ago


Houston, Texas, United States CTMC Full time
Job Title: QA Specialist III

Job Summary:

CTMC is seeking a highly skilled QA Specialist III to join our team. The successful candidate will be responsible for performing system admin responsibilities for Veeva, managing the creation, review, approval, and issuance of GxP controlled site documents and records, and administering QMS training.

Responsibilities:

  • Perform system admin responsibilities for Veeva, ensuring seamless integration and optimal performance.
  • Manage the creation, review, approval, and issuance of GxP controlled site documents and records, maintaining accuracy and compliance.
  • Administer QMS training, developing and delivering training programs to ensure team members are equipped with the necessary skills and knowledge.
  • Monitor and support the implementation and execution of electronic systems, identifying areas for improvement and optimizing user experience.
  • Collaborate with cross-functional departments to ensure alignment of processes, systems, and procedures within Veeva, driving continuous improvement and user experience.

Qualifications:

  • Bachelor's degree in a scientific field, such as biology, chemistry, or a related field.
  • 3+ years of experience in a related field, preferably QA or equivalent combination of education and experience.
  • Strong understanding of Cell and Gene Therapies, cGMPs, GLPs, and GXPs.
  • Excellent verbal and written communication skills, with the ability to effectively communicate with cross-functional teams.
  • Interpersonal and customer service skills, with the ability to build strong relationships with colleagues and stakeholders.
  • Organizational skills and attention to detail, with the ability to prioritize tasks and meet deadlines.
  • Proficient with Microsoft Office Suite or related software, with the ability to learn new systems and technologies.

Working Conditions:

The incumbent in this position works in an office environment, using computer, printer, fax, and telephone equipment. The incumbent must be able to lift up to 15 pounds at times and perform activities in the manufacturing suite and raw material area when applicable.

Reasonable Accommodations:

CTMC is committed to providing reasonable accommodations to individuals with disabilities. If you require accommodations, please notify us in advance.



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