QC Specialist I jobs in United States
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Kite Pharma · 20 hours ago

QC Specialist I

Kite Pharma is a biopharmaceutical company focused on developing innovative cancer immunotherapies. The QC Specialist I role involves performing testing and maintaining equipment to ensure compliance with quality control processes in the development of cancer therapies.

BiotechnologyHealth CareMedicalOncologyTherapeutics
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Perform testing of raw materials, intermediates, final products, and stability by following analytical methods
Maintain, calibrate, and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA, and PCR assays
Track and test products according to stability protocols
Work with internal and external resources to maintain the lab in an optimal state
Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance, and drug product release. Generate Certificates of Analysis (CoAs) for product release
Assist in the preparation of dossiers and data packages for interactions between Kite (Gilead) and regulatory agencies; participate in Pre-Approval Inspections
Develop, revise, and review SOPs, qualification/validation protocols, and reports
Conduct investigations regarding out-of-specification (OOS) results and manage deviations related to analytical procedures. Provide updates at daily and weekly meetings
Monitor GMP systems to ensure compliance with documented policies
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies as appropriate
Gather metric information for continuous improvement of areas of responsibility
Perform other duties as required

Qualification

GMP knowledgeQuality control processesAnalytical techniquesOOS investigationsMS Office proficiencyWritten communicationVerbal communicationIndependent workFlexibility

Required

BS degree in a scientifically oriented field and at least 2 years related work experience
OR MS degree in a scientifically oriented field and at least 0 years related work experience

Preferred

At least 2 years of industry experience in a biotech and/or pharmaceutical quality-related role
Strong knowledge of GMP, SOPs, and quality control processes
Experience identifying, writing, evaluating, and closing OOS investigations
Proficient in MS Word, Excel, PowerPoint, and other applications
Strong written and verbal communication skills
Ability to communicate and work independently with scientific/technical personnel
Well-versed in analytical techniques such as Flow Cytometry, ELISA, PCR, and cell bioassays for biopharmaceutical testing
Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211)
Flexibility to work alternate schedules, including weekends, as business needs require

Benefits

Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Company

Kite Pharma

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Kite Pharma is a biotechnology company that designs and develops immune-based therapies to treat cancer indications.

H1B Sponsorship

Kite Pharma has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (47)
2023 (54)
2022 (59)
2021 (53)
2020 (38)

Funding

Current Stage
Public Company
Total Funding
$335.38M
Key Investors
Alta Partners
2017-08-28Acquired
2015-12-10Post Ipo Equity· $250.12M
2014-06-20IPO

Leadership Team

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Craig Vermeyen
Director, Packaging and Labeling
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Mark Jurgens
Executive Director, Head of External Scientific Collaboration
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Company data provided by crunchbase