Quality Analyst
Duration: 12 months
Location: Rochester, NY
Shift: Monday–Friday, rotating every 2 weeks
About the RoleSeeking a Quality Analyst I to support its manufacturing operations by performing product release testing and data analysis in a BL2 laboratory environment. The ideal candidate will be detail-oriented, organized, and comfortable working in a regulated, FDA-compliant setting.
Key ResponsibilitiesPerform laboratory testing and data analysis for product release.
Operate, maintain, and troubleshoot Vitros 350, FS 5,1, 3400, and 4600 analyzers.
Partner with Manufacturing Operations, Product Support, and Technical Support teams to ensure product quality.
Follow test designs and analyze data to support production releases.
Maintain accurate documentation in compliance with FDA/cGMP requirements.
Work with data management systems such as LIMS, SAP, Windchill (DMS), and QERTS for Non-Conformance & CAPA tracking.
Follow all safety and PPE protocols while handling human samples.
QualificationsBachelor’s degree (Science discipline preferred).
1–2 years of relevant laboratory or manufacturing experience.
Hands-on experience with lab analyzers or related instrumentation.
Familiarity with LIMS, SAP, and documentation systems preferred.
Strong attention to detail, documentation accuracy, and organizational skills.
Understanding of cGMPs, Quality Control, and FDA regulations.
Ability to work independently and collaboratively in a fast-paced environment.
Comfortable standing for long periods and working in a laboratory with PPE.
Why JoinOpportunity to work with a global leader in diagnostic solutions.
Gain hands-on experience in a regulated, quality-driven environment.
Competitive hourly pay and long-term contract stability.