Quality Assurance Specialist I (MQA) jobs in United States
cer-icon
Apply on Employer Site
company-logo

Genentech · 6 hours ago

Quality Assurance Specialist I (MQA)

Genentech is a leading drug product and finished goods manufacturing organization responsible for delivering Roche’s commercial portfolio and pipeline products. The Quality Assurance Specialist I role involves supporting manufacturing activities, documentation review, and initial discrepancy management while collaborating with cross-functional teams to ensure compliance with quality standards.

BiotechnologyLife ScienceManufacturing
check
Comp. & Benefits
check
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 reviewProblem solvingCommunication skillsAttention to detail

Required

You hold a B.A./B.S. degree 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

Preferred

preferably in Life Science

Benefits

Discretionary annual bonus
Relocation benefits

Company

Genentech

company-logo
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

leader-logo
Ashley Magargee
CEO
linkedin
leader-logo
Michael Laird
Vice President
linkedin
Company data provided by crunchbase