Quality Assurance Specialist I (MQA) jobs in United States
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Roche · 14 hours ago

Quality Assurance Specialist I (MQA)

Roche is a leading pharmaceutical company focused on delivering life-saving medicines. The Quality Assurance Specialist I will provide essential support for manufacturing activities, documentation review, and initial discrepancy support in a regulated environment.

BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

You will provide basic Quality Assurance support for routine GMP activities in manufacturing at HTO
You will partner with experienced team members to provide floor support, initial batch record review steps, and discrepancy management (Quality Incidents and Minor Deviations)
You will resolve routine Quality Assurance issues limited in scope and complexity following cGMP regulations
You will execute daily tasks and complete documentation review with low to moderate supervision
You will collaborate cross functionally to ensure that all review activities are executed efficiently and effectively
You will support Quality process improvement initiatives by contributing data collection or assisting with minor tasks as directed

Qualification

CGMP knowledgeDocumentation reviewLife Science degreeQuality standards interpretationProblem solvingCommunication skillsAttention to detailFlexibility

Required

You hold a B.A./B.S. degree (preferably in Life Science) with 1-3 years of relevant experience in a regulated environment, or an equivalent combination of education and experience
You are able to perform physical activity including, but not limited to lifting, standing for periods of time, and gowning
You have basic knowledge or familiarity with cGMPs or equivalent regulations
You have experience or a strong aptitude for reviewing documentation with high attention to detail
You are able to learn to interpret and relate Quality standards for implementation and review
You are able to evaluate situations and propose potential solutions
You are able to communicate clearly and professionally both in writing and verbally
You have a flexible and adaptable approach to problem solving, learning new tasks and meeting business objectives

Benefits

A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for the benefits detailed at the link provided below.
Please note this role is eligible for relocation benefits.

Company

Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.

H1B Sponsorship

Roche 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 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)

Funding

Current Stage
Public Company
Total Funding
$7.79B
Key Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M

Leadership Team

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Alan Hippe
Member of the Executive Board - Group CFO
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Christine Bakan
Global Head and VP of Software and Bioinformatics, Next Generation Sequencing
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Company data provided by crunchbase