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

Position Overview
The Quality Control Specialist II will be responsible for performing assays for product release in accordance to GMPs, SOPs and FDA regulations.

Position Responsibilities

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

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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QC Specialist II