QC Specialist II
- Location: Houston, TX
- Type: Direct Hire
- Job #38257
Looking for a QC specialist that has experience in cell therapy to work with an innovative immuno-oncology company to provide T-cell development for meaningful cancer treatments!
This company covers all health benefits and has Unlimited PTO!
Pay: $65-75K DOE
Schedule: Mon-Fri 8a-5p
Location: Houston, TX
The Quality Control Specialist II will be responsible for performing assays for product release in accordance to GMPs, SOPs and FDA regulations.
- 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 scientific field, Master’s degree preferred.
- 2-years of experience working in in an aseptic manufacturing environment
- Experience in Cell therapy analytical methods including Flow Cytometry, ELISpot and cell counting
- Knowledge of cGMP and FDA regulations