Quality Assurance Specialist I jobs in United States
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Curia · 23 hours ago

Quality Assurance Specialist I

Curia is a global contract development and manufacturing organization focused on providing life-saving treatments. The Quality Assurance Specialist I will maintain quality databases, ensure compliance with cGMPs, and manage corrective actions in manufacturing operations.

BiotechnologyHealth CareManufacturing
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H1B Sponsor Likelynote

Responsibilities

Maintain Quality databases including Archival and scanning of cGMP documents and records, Departures, media fill programs, and training files
Represent Curia Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented
Solicit feedback from various departments for operational improvement
Author, review, and/or approve Quality Management System documents, including, but not limited to, change controls, SOPs, deviations, CAPAs, etc
Assist in performing investigations
Perform and/or assist with internal audits, weekly walkthroughs, and/or external audits
Perform QA visual inspection activities associated with clinical and commercial drug product
With supervision, may respond or manage responses to clients regarding manufacturing and/or documentation issues
Develop and/or maintain Quality System metrics for management review
Assist in tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs

Qualification

CGMP complianceQuality Management SystemLife Science degreeFDA regulationsCommunicationAttention to detailProblem solvingCritical thinking

Required

Bachelor's degree in Life Science or related field
Minimum 0-3 years' experience in a cGMP and FDA-regulated industry
Excellent verbal and written communication skills
Focused self-starter with attention to detail
Team-oriented, but able to work independently and proactively
Ability to multi-task
Strong problem solving and organizational skills
Strong critical thinking skills, including familiarity with root-cause analysis

Preferred

Gowning qualification (may be required)

Benefits

Generous benefit options
Paid training, vacation and holidays
Career advancement opportunities
Education reimbursement
401k program
And more!

Company

Curia is a biotechnology company that offers discovery biology, synthetic, medicinal chemistry, and small-scale manufacturing services.

H1B Sponsorship

Curia 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 (34)
2024 (17)
2023 (8)

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-03-07Debt Financing
2017-08-31Private Equity

Leadership Team

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Steve Lavezoli
Vice President, Biologics Division
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Company data provided by crunchbase