Senior Technician Quality Control

Senior Technician Quality Control

Location: Tarzana, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 8 months (possible extension)
• Pay Rate: $40.00 $52.00 / 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, it 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, including relevant GxP requirements.

At the client's Oncology R&D division, they follow the science to explore and innovate working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. The team has the potential to grow the pipeline and positively impact the lives of billions of patients around the world. They are committed to making a difference and have built their business around their passion for science, 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 of experience; OR an Associate's degree with 4 years of experience; 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.

Work Environment / Physical Requirements

• In-person, on-site role in Tarzana, CA.
• On average, a minimum of three days per week from the office is expected (role context); the assignment is fully on-site.
• Possible weekend work (Sunday Thursday schedule or Monday Friday with possible weekend work).

Important Notes

• Candidates must have QA experience clearly listed on their resume along with pre-screening question responses.
• Pre-screening questions (responses must be attached to resume):

- How would you explain a deviation and how it was handled? - How do you manage batch record reviews? - For on-the-floor support, what do you look for?

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

Benefits

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

About the Client

This client is a global biopharmaceutical and life sciences organization with a dedicated Oncology R&D division, operating across strategic locations including California and Maryland. The organization employs thousands of professionals including quality assurance specialists, cell therapy scientists, R&D communications directors, and manufacturing operations staff who collaborate across clinical, scientific, and technical functions. With a focus on treating, preventing, and potentially curing complex diseases, the client ranks among the leading names in oncology drug development globally, advancing a growing pipeline that spans cell therapy and other cutting-edge modalities.

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: 26-14681 Industry: Manufacturing & Operations

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