Quality Assurance Specialist

Quality Assurance Specialist

Location: Santa Monica, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 8 months (possible extension)
• Pay Rate: $35.00 $38.00 / 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.

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Job Summary

This role 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, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we 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 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.

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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.

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Required Experience

• 2 4 years of Cell Therapy experience.
• Experience writing, evaluating, and closing investigations, CAPAs, and change control.
• Ability to adapt best practices for stage-appropriate products.

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Required Skills

• Knowledge of and ability to apply GMP in conformance with US standards.
• Proficient in cGMP regulations, quality systems, and regulatory requirements.

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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.

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Work Environment / Physical Requirements

• This is an on-site role located in Tarzana, CA.
• In-person working is expected a minimum of three days per week from the office on average, with balance given to individual flexibility.
• Possible weekend work may be required.

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Important Notes

• Candidates must have QA experience clearly listed on their resume.
• Candidates must answer the following pre-screening questions and attach responses to their 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 both via Microsoft Teams, each approximately 30 minutes in duration.

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Benefits

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

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About the Client

This client is a leading biopharmaceutical and life sciences organization with a dedicated Oncology R&D division, operating across strategic U.S. locations including Southern California and the greater Mid-Atlantic region. The organization employs thousands of professionals across scientific, clinical, regulatory, and quality functions including QA Specialists, cell therapy experts, R&D communications directors, and external affairs leaders. With a pipeline focused on treating, preventing, and curing some of the world's most complex diseases, this client is recognized for its science-led mission and commitment to advancing next-generation therapies for patients worldwide.

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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.

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Job Number: 26-09321 Industry: Manufacturing & Operations

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