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.
P1
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
