Curia · 2 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
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
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
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 StageTotal Funding
unknown2025-03-07Debt Financing
2017-08-31Private Equity
Recent News
2026-01-20
2025-10-31
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2025-10-29
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