Quality Control Associate jobs in United States
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Genentech · 3 hours ago

Quality Control Associate

Genentech is dedicated to advancing cell and gene therapies aimed at treating or curing various diseases. The Quality Control Associate will support the clinical development and manufacturing of cell therapies by performing analytical development and quality control activities to ensure product quality and compliance.

BiotechnologyLife ScienceManufacturing
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Validate, qualify, and troubleshoot analytical methodologies to support clinical production and GMP operations
Execute and oversee analytical testing activities related to process development, IPC, and product release
Collaborate with technical development teams, PTC functions, and global stakeholders to align on project timelines, quality criteria, and regulatory compliance
Develop and implement SOPs, specifications, and testing methods, ensuring compliance with cGMP regulations and continuous improvement principles
Conduct technical review of data and identify gaps, deviations, or discrepancies, escalating issues as needed
Perform equipment qualification, maintenance, and validation of laboratory instruments and computer systems
Support internal and external audits and regulatory inspections while contributing to the evolution of business processes and operational excellence initiatives

Qualification

Analytical methodologiesCGMP regulationsLaboratory equipment maintenanceQuality standards interpretationTechnical writingProblem-solvingCommunication skillsTeam collaboration

Required

Bachelor's degree and at least 3 years of relevant experience, or a Master's degree with one year of experience, or an equivalent combination of education and experience in Chemistry, Biochemistry, Molecular Biology, or a related scientific discipline within the pharmaceutical or biopharmaceutical industry
Sound knowledge of cGMPs or equivalent regulations and the ability to interpret and apply Quality standards for implementation and review
Demonstrate the ability to work independently to accomplish tasks and apply scientific theories, principles, and techniques used in analytical or biological test procedures
Strong verbal and written communication skills, with the ability to organize and present information clearly both formally and informally
Flexibility in problem-solving, adapting to work hours, and meeting business objectives while maintaining a high standard of work
Ability to work in an office and laboratory environment, with prolonged periods of standing/sitting at lab bench tops, frequent lifting (up to 25 lbs), bending, reaching, twisting, and use of stepladders and pushcarts
Meet physical requirements such as passing visual screening and may travel to other sites as required

Benefits

A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for the benefits detailed in this link.

Company

Genentech

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Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.

H1B Sponsorship

Genentech 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 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)

Funding

Current Stage
Public Company
Total Funding
unknown
2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown

Leadership Team

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Ashley Magargee
Chief Executive Officer
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Michael Laird
Vice President, Global MSAT Drug Substance Biologics Technology and Commercial Products Support
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Company data provided by crunchbase