Kelly® Science & Clinical is seeking a Senior Quality Assurance Associate, Immunotherapy for a 6-month contract opportunity with one of our clients, a commercial-stage biotechnology company in the Los Angeles, CA area. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Position Title: Senior Manufacturing Quality Associate
Position Type: 6-month contract
Pay rate: $45-50 per hour
Workplace: Onsite in the Los Angeles, CA area
Schedule: Monday-Friday, 10am-6:30 pm
Overview
Join a pioneering biopharmaceutical organization at the forefront of personalizing cancer treatment. We develop and manufacture cutting-edge immunotherapies that harness a patient’s own immune system to fight cancer. Our breakthrough therapies, manufactured using advanced cell processing and aseptic techniques, represent the next generation of individualized medicine.
With state-of-the-art Immunotherapy Manufacturing Facilities located in Seal Beach, CA, and a collaborative team of industry leaders across the country, we are dedicated to transforming lives through scientific excellence and innovation.
Overview
Role Summary:
As a Senior Quality Specialist I, Manufacturing Quality, you will play a pivotal role in ensuring compliance with regulatory standards across our manufacturing operations. You will support all phases of production and quality oversight, safeguarding the integrity of our advanced therapeutics.
Responsibilities

• Oversee batch record management, including issuance, review, and closure.
  

• Manage receipt of patient materials and prepare final product shipments.
  

• Execute final product disposition and release.
  

• Review and approve raw materials and GMP facility work orders.
  

• Evaluate and endorse validation protocols, reports, and various qualification documents.
  

• Investigate product complaints, deviations, and non-conformances.
  

• Analyze and report quality metrics, escalating issues to senior management as needed.
  

• Lead and assess change controls, including risk assessments and impact reviews.
  

• Represent Quality in cross-functional teams and GXP issue resolution.
  

• Employ advanced problem-solving skills within highly regulated environments.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience (10+ years relevant experience may substitute degree).
  

• Minimum of 7 years in a cGMP-regulated biopharma, biotechnology, or cell therapy environment.
  

• Strong knowledge of FDA, ICH, and international cGMP guidelines.
  

• Experience with aseptic, sterile products manufacturing and clean room protocols preferred.
  

• Working knowledge of facility operations (ISO classifications, air handling systems), and MS Office proficiency.
  

• Must be able to gown aseptically for clean room work.

Working Conditions:

• Office, laboratory, and manufacturing environments; some exposure to noisy settings and cold storage.
  

• Must be comfortable working in proximity to blood, blood products, and other biologic materials while using appropriate PPE.
  

• Ability to lift up to 25 pounds, and perform standard physical tasks including computer use and paperwork.

Your Impact
If you thrive in a fast-paced, innovative environment and are passionate about advancing immunotherapy manufacturing in the Los Angeles area, we invite you to make a difference with us. Your dedication will contribute directly to bringing breakthrough cancer treatments to patients who need them most.
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