QA Specialist - Cell Therapy

QA Specialist - Cell Therapy

Location: Santa Monica, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 8 months (possible extension)
• Start: June 29, 2026
• Pay Rate: $35.00-$40.00 / Hour (USD)
• Shift / Schedule: 9 AM - 5 PM, Sunday-Thursday OR Monday-Friday (possible weekend work)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

Provides Quality Assurance support to an assigned area. Typically, a graduate or equivalent. Non-supervisory, provides technical advice in key areas of processes and procedures. The role holder impacts directly on the value stream by ensuring efficient processes and procedures are maintained within the boundaries of regulatory compliance. For relevant GxP.

At the client's Oncology R&D division, they follow the science to explore and innovate. They are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here there is the potential to grow the pipeline and positively impact the lives of billions of patients around the world. The client is committed to making a difference and has built its business around a passion for science. Now they are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

The Specialist, Quality ensures compliance with the quality system's procedures and assesses. This unique role is accountable for routine Quality Assurance responsibilities related to the production and disposition of products manufactured and tested on behalf of the client. This role is based in Tarzana, CA, and reports to the Manager, QA.

Key Responsibilities

• Provide quality assurance support across technical operations functions (i.e., Manufacturing, Facilities & Engineering, Supply Chain, Quality Control, Analytical Development, Product Development/Manufacturing Sciences & Technology) within the client to ensure compliance with the quality manual and maintain collaborative quality relationships.
• Lead deviations and laboratory investigations related to GMP manufacturing and analytical testing, respectively, with cross-functional owners. Determine corrective/preventative actions (CAPA) and Verification of Effectiveness (VoE) and drive on-time implementation and closure.
• Work with appropriate partners to manage change controls in a phase-appropriate manner for clinical stage products that support quality risk management (i.e., New Product Introduction, New Facility, & Manufacturing Process Change Controls).
• Provide ILT training for annual GMP/GDP, Quality Manual, Quality Risk Management, Deviation/CAPA, and Change Control.
• Work with QA doc control to ensure accurate issuance of batch record documentation (i.e., lot/media batch records and in-process/QC/final product labels) to manufacturing.
• Review routine manufacturing batch documentation and quality control data for in-process and finished products to support disposition and lot closure.
• Perform approval of equipment alarm acknowledgements, equipment activation, and PM/Calibration schedules in computerized asset and alarm management system(s).
• Review routine material release documentation for the quality release of raw materials used for manufacturing and quality control testing.

Education Requirements

• MA/MS in Biology, Chemistry, Microbiology, Engineering, or a related field is required, or a BA/BS with 2 years, an Associate's degree with 4 years, or a High School diploma with 5 years of Quality Assurance or GMP experience.

Required Experience

• 2-4 years of Cell Therapy experience.
• Experience writing, evaluating, and closing investigations, CAPAs, and change control.

Required Skills

• Knowledge of and ability to apply GMP in conformance with US standards.
• Proficient in cGMP regulations , quality systems, and regulatory requirements.
• Ability to adapt best practices for stage-appropriate products.

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

Important Notes

• Interview Process: 2 rounds - 1st Teams Interview (30 minutes); 2nd Teams Interview (30 minutes).

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-06896 Industry: Manufacturing & Operations

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