Curia · 3 months ago
Quality Assurance Specialist II
33 Riverside Avenue, Rensselaer, NY, 12144, US
Full-time
Onsite
Mid Level
$102K/yr - $102K/yr
3+ years expCuria Global Inc. is seeking a Quality Assurance Specialist II for its Rensselaer, NY location. The role involves assisting with validation activities throughout the plant, providing technical assistance to various departments, and ensuring compliance with quality assurance standards.
BiotechnologyHealth CareManufacturing
Responsibilities
Develop and maintain a thorough understanding of cGMPs and associated regulations. Make suggestions for quality system improvements and recommend methods to increase the quality of products and/or services. Participate in the implementation of these improvements
Assist in cleaning, process and equipment validation activities throughout the plant. This includes development of validation strategies to align with the site operations and business priorities, coordinate and execute validation and cGMP-related activities of Engineering Services, R&D, Production, Maintenance and QA/QC as necessary
Prepare and review validation plans, protocols and reports appropriate to define and document validation activities
Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards
Prepare and conduct Cleaning Validation Studies per Internal Master Plan
Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems
Use data analysis techniques and software, review test results to determine the main cause of defects, safety risks, and performance problems. Additionally, use the data to provide a risk assessment and check for adherence to regulatory standards
Maintain validation procedures and appropriate documentation to support installation, operational, cleaning and performance testing
Manage and ensure validations plans are completed in accordance with project timetables
Review and approve change controls and qualification/validation documentation. Authorize equipment for use and product release
Provide training on validation issues and documentation
Communicate validation issues and requirements to plant personnel on a frequent basis through participation in Engineering, R&D and management staff meetings, and applicable project teams
Track all validation documentation throughout the plant and follow-up as needed
Drive continuous improvement efforts for the site validation program
Participate in self-development activities and training of others
Exhibit safety awareness and safe work practices
Perform other quality functions as necessary or as requested. Perform other duties as may be reasonably assigned in the course of business; and
Maintain awareness of current regulatory trends and practices. Assist in FDA and customer audits
Qualification
Required
A Bachelor's degree in Biomedical Engineering or a related field
Three (3) years of experience as a validation specialist or biomedical engineer, which includes 1 year of experience with the following: Conducting root cause analysis and deviations; Performing cleaning validation; and Managing compliance with industry standards and maintaining Standard Operating Procedures (SOPs)
A Master's Degree in Biomedical Engineering, or a related field
One (1) year of experience as a validation specialist or biomedical engineer, which includes 1 year of experience with the following: Conducting root cause analysis and deviations; Performing cleaning validation; and Managing compliance with industry standards and maintaining Standard Operating Procedures (SOPs)
Company
Curia
Curia is a biotechnology company that offers discovery biology, synthetic, medicinal chemistry, and small-scale manufacturing services.
1001-5000 employees
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
Leadership Team
Steve Lavezoli
Vice President, Biologics Division
Recent News
2026-01-20
2025-10-31
thecanadianpressnews.ca
2025-10-29
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