Actalent • Santa Monica, CA 90407
Job #2690223125
LARGE cell therapy company in Santa Monica is looking for a Quality Control Associate to join their analytical team! GMP experience with analytical assay experience required. APPLY NOW!
*** For a response within 2 business days please email a copy of your resume to ralfred @actalentservices ***
What's in it for you:
Join a large cell therapy company with approved products on the market
Opportunity to grow within the industry
Robust internal culture
GMP and cleanroom experience
Assay experience: flow cytometry, mammalian cell culture, ddPCR, cytotoxicity
Ability to work 4x10 - Sunday-Wednesday, 1st shift
Conduct Quality Control Analytical testing (e.g., ELISA, Flow Cytometry, PCR) of patient samples, stability samples, controls, and reagent qualification in a GMP environment. Perform reviews of assays and maintain laboratory in a state of compliance.
Troubleshoot instrumentation and test methods.
Assists in the training of QC staff as needed.
Applies knowledge of current Good Manufacturing Practices (cGMPs) and Good Laboratory Working knowledge and proficiency with Microsoft Office software.
Writes and executes protocols and SOPs.
Execution of complex biological assays with high technology instrumentation per SOPs
Perform hands-on laboratory testing utilizing various analytical techniques including ddPCR, flow cytometry, cell counting, and cytotoxicity assays in support of MP clinical manufacturing.
Perform cell culture work to support cGMP clinical manufacturing.
Perform statistical and analytical analysis of experiments as appropriate to ensure analytical assay trending and control; contribute to data packages for regulatory agencies, presentations, and publications.
Write and revise SOPs and technical / summary reports with some supervision.
Execution of QC assay studies or qualifications to meet laboratory GMP requirements under supervision
Support analytical technology transfer from Research and Process Development to Quality Control.
Perform and document quality investigations to support out-of-specification results and data summaries.
General QC laboratory maintenance and EH&S
Operate, qualify, and maintain equipment within the Quality Control laboratory.
Follow all Quality standards and environmental health and safety guidelines.
Support setup and implementation of a Quality Control Laboratory.
Continuous improvement of Assay procedures
Author continuous improvement of Assay procedures under supervision
Work cross-functionally with Preclinical Discovery, Translational Sciences, Clinical Development, Clinical Operations, Biometrics, Regulatory and Safety to execute on corporate goals.
Mammalian cell culture, qPCR, Report writing, cGMP, ddPCR, SOP revision, flow cytometry, method development, assay development
Intermediate Levella
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email ~~~ (~~~) for other accommodation options.
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