Quality Assurance Specialist III jobs in United States
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Curia · 8 hours ago

Quality Assurance Specialist III

Curia is a global contract development and manufacturing organization focused on providing life-saving treatments. The Quality Assurance Specialist III is responsible for maintaining Quality Systems and ensuring compliance with cGMPs while working cross-functionally to support manufacturing operations.

BiotechnologyHealth CareManufacturing
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H1B Sponsor Likelynote

Responsibilities

Work cross-functionally with Manufacturing, Process Engineering, Technical Operations, Inspection, and Project Management to support Right First-Time execution of operations at the site
Review Executed batch records, quality control testing data, and environmental monitoring data for compliance with internal SOPs and specifications, assess lot associated deviations, CAPA, and change controls for cumulative impact, and conduct Batch disposition for clinical, developmental, and commercial products
Review and approve procedural changes
Attend client meetings and manage responses to clients regarding manufacturing and/or documentation issues
Review and approve protocols and executed validation documentation
Work in coordination with the QA Management to ensure client timelines are on schedule and attainable
Author or revise SOPs
Assist or review deviations and OOS investigations
Assist in developing and delivering training
Develop and/or present metrics for Management Review
Assist in the compilation of documentation, systems, and controls to ensure inspection-ready quality systems (ISO, FDA, QP, EMEA) for regulatory and client audits
Participate in regulatory and client audits
Represent CURIA Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and appropriately documented
Other duties may be assigned

Qualification

GMP experienceQA experienceFDA regulationsCommunicationProblem-solving skills

Required

Bachelor's Degree with a minimum of 5 years' GMP and QA experience in an FDA-regulated pharmaceutical environment
Excellent written and verbal presentation and communication skills
Strong problem-solving skills, with the ability to resolve conflict
Ability to effectively present information to management and/or peers
Comfortable working independently in combination with individuals in other departments across the organization
Must pass a background check
Must pass a drug screen
May be required to pass Occupational Health Screening

Benefits

Generous benefit options (eligible first day of employment)
Paid training, vacation and holidays (vacation accrual begins on first day of employment)
Career advancement opportunities
Education reimbursement
401K program with matching contributions
Learning platform
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