Quality Control Specialist

4 weeks ago


Houston, Texas, United States CellReady™ Full time
Job Title: QC Specialist

Cell Ready is seeking a highly skilled QC Specialist to join our team in Houston, Texas. As a key member of our quality control team, you will be responsible for ensuring the highest standards of quality in our cell and gene therapy manufacturing processes.

Responsibilities:
  • Perform in-process and release testing, as well as routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, and stability samples.
  • Qualify and validate QC assays, maintain accurate and concurrent testing records, and interpret results to analyze trends and report findings to the head of quality control and other departments as needed.
  • Support the maintenance of all QC laboratory equipment, and assist in the transfer of methods to the QC lab.
  • Review paperwork of other specialists to ensure accuracy prior to submission to QA.
  • Collaborate with cross-functional teams to ensure compliance with FDA, CDC, EPA, and OSHA guidelines.
  • Develop and qualify new testing methods, and prepare or review required method transfer documentation.
  • Assist in training of new hires and retraining of QC laboratory staff, as needed.
Requirements:
  • Bachelor's Degree in Life Sciences discipline, or relevant experience in the fields of Biotech/Pharma/Cell Therapy.
  • 1-3 years' experience in a cGMP analytical lab environment.
  • Experienced in Method Transfer preferred.
  • Experience in quality control of cells from human tissue origin preferred.
  • Experience in current Good Manufacturing Practice (cGMP) environment preferred.
  • Strong organizational, multitasking, problem-solving, math, statistical, interpersonal, written, and oral communication skills.
  • Ability to work within multi-functional teams, and function well in a fast-paced environment.
  • Strong manual dexterity, and ability to read and interpret work instructions with a high level of accuracy.
  • Ability to communicate with all levels of staff clearly and professionally.
Why Join Us:
  • Be an instrumental part of a team that will play a critical role in providing society with widespread access to Cell and Gene Therapies.
  • Work with a well-funded company with no debt.
  • Enjoy a rare opportunity to combine meaningful work with exceptional compensation.


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