QC Analytical Chemist – Medical Diagnostics, HPLC

bioMerieux Inc.; Hazelwood (MO); Vor Ort; USD 59.000 - 88.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision plans

Retirement plan with company match

Wellness programs

Commuter benefits

Employee assistance program

Zusammenfassung

bioMerieux Inc. is seeking an experienced QC analytical laboratory professional to ensure quality, safety, and regulatory compliance of materials and products for commercial medical device diagnostic manufacturing.

The role entails analytical testing, data integrity, and collaboration with Manufacturing, QA, R&D, and Engineering to support uninterrupted operations. The successful candidate will operate and maintain analytical instruments, review data for GDP/ALCOA+ compliance, and contribute to

Qualifikationen

• Bachelor's degree in Chemistry, Analytical Chemistry, Biology, Biochemistry, or related science discipline.
• 3+ years of QC analytical laboratory experience, including FDA-regulated environments.
• Experience with cGMP, GLP, GDP and compliance requirements.

Aufgaben

• Perform testing of raw materials, reference standards, in-process materials, finished products, and stability samples.
• Operate, troubleshoot, and maintain HPLC, IC, FTIR, UV-Vis, conductivity, pH, titration systems, balances, and related equipment.
• Review data for GDP and ALCOA+ compliance.
• Support OOS, OOT, deviations, CAPA, nonconforming-material investigations, root cause analysis, method verification, validation, transfers, qualification, calibration, and preventive maintenance.
• Partner cross-functionally on disposition and production schedules.
• Maintain records under FDA, ISO 13485, cGMP, GLP, and QMS requirements.
• Support continuous improvement, technical reporting, procedure revisions, training, and mentoring.

Kenntnisse

Analytical

Troubleshooting

Organizational

Communication

Ausbildung

Bachelor's degree in Chemistry/Analytical Chemistry/Biology/Biochemistry

Tools

HPLC

FTIR

UV-Vis

IC

pH/Conductivity/Titration systems

MS Office (Outlook/Word/Excel)

QMS tools (TrackWise, SAP)

Jobbeschreibung

bioMerieux Inc. is seeking an experienced QC analytical laboratory professional to ensure quality, safety, and regulatory compliance of materials and products for commercial medical device diagnostic manufacturing.

The role entails analytical testing, data integrity, and collaboration with Manufacturing, QA, R&D, and Engineering to support uninterrupted operations. The successful candidate will operate and maintain analytical instruments, review data for GDP/ALCOA+ compliance, and contribute to