Associate, Quality Control Analytical, Cell Therapy jobs in United States
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AstraZeneca · 2 hours ago

Associate, Quality Control Analytical, Cell Therapy

AstraZeneca is a global biopharmaceutical company, and they are seeking an Associate for their Quality Control Analytical team. The role involves supporting cGMP lot release and stability testing for cell therapy products, focusing on routine analytical testing, sample preparation, and maintaining documentation with high data integrity.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Routine analytical testing: Complete assays under supervision (e.g., automated cell counting, viability, ELISA, PCR, flow cytometry, basic cell culture handling) following approved methods and cGMP/GDP expectations
Sample and reagent preparation: Prepare reagents, controls, and standards; perform sample receipt, labeling, and chain-of-custody according to SOPs
Instrument operation: Operate assigned instruments per SOPs including daily checks, calibrations, and routine maintenance
Documentation and data integrity: Record data contemporaneously in relevant electronic systems; ensure completeness, accuracy, and compliance with ALCOA+ principles
Lab support and readiness: Maintain inventory of consumables and reagents; perform lab housekeeping, 5S, and equipment cleaning; support sample logistics and courier/chain-of-custody processes
Quality systems participation: Assist in documenting deviations and events; provide data and observations for investigations (e.g., OOS/OOT); follow implemented CAPAs and change controls
Training and qualification: Complete method training and analyst qualifications; maintain proficiency through periodic reassessments; seek feedback and demonstrate continuous learning
Collaboration and communication: Communicate testing status, material needs, and issues to the team; support scheduling and sample coordination to meet lot release timelines

Qualification

CGMP awarenessLaboratory techniquesDocumentation practicesCollaborationAttention to detailSchedulingGrowth mindset

Required

Basic hands-on experience with laboratory techniques relevant to cell therapy or biologics (e.g., pipetting, aseptic technique, ELISA basics, PCR setup, cell counting/viability)
Understanding of core cGMP concepts, Good Documentation Practices, and laboratory compliance; ability to follow SOPs precisely and ask clarifying questions
Strong focus on right-first-time execution, accurate record-keeping, and timely response to escalation of discrepancies
Demonstrates effective cross-functional collaboration, accepts flexibility in a constantly evolving environment, and maintains a positive, solutions oriented attitude to drive outcomes
Enthusiasm to develop new technical skills and expand responsibilities with experience
Ability to work on-site in a lab-based role; willingness to support off-hours/weekend testing as needed to meet patient supply timelines
Associate's degree with relevant lab experience may be considered
At least one year of laboratory experience in a pharmaceutical/biotech or related academic setting. Exposure to QC, cGMP environments, or regulated documentation is a plus

Preferred

Bachelor's degree in Biological Sciences, Chemistry, Biochemistry, or related discipline

Benefits

Qualified retirement programs
Paid time off (i.e., vacation, holiday, and leaves)
Health, dental, and vision coverage in accordance with the terms of the applicable plans

Company

AstraZeneca

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AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

H1B Sponsorship

AstraZeneca 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
2021 (2)
2020 (11)

Funding

Current Stage
Public Company
Total Funding
$5.26B
2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B

Leadership Team

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Pascal Soriot
Chief Executive Officer
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Aradhana Sarin
Group CFO and Executive Director
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Company data provided by crunchbase