Cell Therapy QC Specialist II/III
- Location: Houston, TX
- Type: Direct Hire
- Job #34977
Quality Control Specialist II
The Quality Control Specialist II will join a small yet strong QC Analytical team that would allow one to be a key figure in day-to-day operations. The position requires an individual who can work in a fast-paced environment, have the technical expertise and the confidence to take on any task needed to complete the required responsibilities. The QC Specialist will be performing assays in support of production, product release and stability studies on company's GMP products and drug components, in accordance to the Quality Control Standard Operating Procedure and in compliance to FDA regulations.
This position will work closely with the Quality Control Director as well as across other departments including Quality Assurance, Manufacturing and Research and Development to support the clinical trials.
- Support all day-to-day functions and perform routine analysis of in-process, finished product and stability samples as outlined in laboratory procedures.
- Author Standard Operating Procedures (SOPs), study protocols and other documents requested by the supervisor.
- Demonstrate technical proficiency in analytical methodology (flow cytometry, ELISpot and cell counting) and adherence to GMP and ICH compliance.
- Participate in assay transfer, qualification and validation studies.
- Analyze, interpret and troubleshoot data and generate technical reports, when required.
- Plan and coordinate with other departments to ensure continuous and timely testing of clinical and stability samples.
- Oversee shipment and testing of analytical samples contracted to CTOs.
- Assist supervisor in investigating the OOS and non-conformances.
- Maintain and care of the laboratory equipment and perform good housekeeping activities.
- Complete all training requirements in timely manner.
- Other duties as assigned.
Skills, Education And Experience Required
- Minimum Bachelor's degree in Biological Sciences, Biotechnology or a related field (Master’s degree is preferred).
- Minimum of 2 years of experience in an aseptic manufacturing environment (cell and gene therapy), preferably with experience in a Quality organization. With preferred degree, 1 year of experience is acceptable.
- Knowledge of cGMP and FDA regulations.
- Experience in cell therapy analytical methods (Flow Cytometry and ELISpot are preferable).
- Experience working with non-conformances and/or laboratory investigations.
- Ability to learn new methods and propose ideas to conducts projects or optimize assays.
- Ability to work both independently without supervision as well as be part of a team, demonstrating excellent communication and interpersonal skills, is required.
- Strong problem solving and analytical skills with demonstrated ability to manage several projects simultaneously is a must.
- Ability to effectively plan and organize work activities and prioritize task completion adhering to schedules and deadlines.
Schedule: Mon-Fri 8a-5p