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)
• 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

This role provides Quality Assurance support to an assigned area. Typically, a graduate or equivalent, this is a non-supervisory position that 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, the team follows the science to explore and innovate, working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. The organization has the potential to grow its pipeline and positively impact the lives of billions of patients around the world, built around a passion for science and now 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 assessments. 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 organization 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.

Required Skills

• Knowledge of and ability to apply GMP in conformance with US standards.
• Proficient in cGMP regulations, quality systems, and regulatory requirements.
• Experience writing, evaluating, and closing investigations, CAPAs, and change control.
• Ability to adapt best practices for stage-appropriate products.

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.

Work Environment / Physical Requirements

• In-person working environment; on average, a minimum of three days per week from the office.
• Possible weekend work depending on schedule assignment (Sunday Thursday OR Monday Friday schedule).

Important Notes

• Interview Process: 2 rounds 1st Teams Interview (30 minutes), 2nd Teams Interview (30 minutes).
• Candidates must have direct QA responsibilities; Quality Control (QC) experience is not equivalent to the QA experience required for this role.
• Role requires hands-on experience with batch record review, batch disposition, deviation management (from a QA reviewer perspective), change controls, and GMP documentation review.
• Product complaint experience alone is not sufficient; the role requires manufacturing QA experience supporting batch review and product disposition.
• Candidates should be prepared to explain in detail: how they handled deviations, how they manage batch record reviews, and what they look for during on-the-floor support.
• The Specialist position is expected to be filled by someone with approximately 2 3 years of directly relevant QA experience who can contribute with minimal training.

Benefits

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

About the Client

This client is a leading biopharmaceutical and life sciences organization operating across strategic locations including the greater Los Angeles area and the Mid-Atlantic region. With a strong focus on Oncology R&D, the organization employs thousands of professionals including quality assurance specialists, cell therapy scientists, R&D researchers, and manufacturing operations personnel who collaborate to advance the next generation of life-changing medicines. The company's pipeline spans innovative cell therapy programs and other complex disease areas, reflecting a commitment to scientific excellence and regulatory rigor that positions it among the top-tier biopharma organizations in the industry.

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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