QC Analytical Chemist — cGMP Medical Devices Lab

bioMérieux SA; Hazelwood (MO); On-site; USD 59,000 - 88,000; Full time

Benefits offered by this job

Medical/Dental/Vision plans (nationwid

Life and AD&D Insurance

Short/Long-Term Disability

Retirement plan with employer match

Adoption Assistance

Wellness Programs

Employee Assistance Program

Commuter Benefits

Voluntary benefits

Discount programs

Parental leaves

Job summary

bioMérieux SA seeks a QC Analyst to ensure quality, safety, and compliance of materials and products used in medical device diagnostics. This role performs analytical testing in a cGMP lab and generates data supporting release, regulatory compliance, and uninterrupted manufacturing.

You will operate HPLC, FTIR, UV-Vis, and IC systems, review data for GDP/ALCOA+ compliance, and support investigations, CAPA, method validation/transfer, and cross-functional collaboration with Manufacturing, QA,

Qualifications

• Bachelor's degree in a chemistry/biological science field is required.
• 3+ years of QC analytical laboratory experience in an FDA-regulated environment is required.
• Experience with cGMP, GLP, GDP, and ISO 13485 is required.
• Hands-on experience with HPLC, FTIR, UV-Vis, and/or IC is required.
• Strong analytical, troubleshooting, organizational, and communication skills are required.

Responsibilities

• 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, investigations, method verification/validation, transfers, qualification, calibration, and preventive maintenance.
• Partner cross-functionally on disposition and production schedules.

Skills

Analytical skills

Troubleshooting

Organizational skills

Communication skills

MS Office (Outlook/Teams/Word/Excel)

Education

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

Tools

HPLC

FTIR

UV-Vis

IC

SAP

TrackWise

QMS

Method validation/transfer

Technical writing

Job description

bioMérieux SA seeks a QC Analyst to ensure quality, safety, and compliance of materials and products used in medical device diagnostics. This role performs analytical testing in a cGMP lab and generates data supporting release, regulatory compliance, and uninterrupted manufacturing.

You will operate HPLC, FTIR, UV-Vis, and IC systems, review data for GDP/ALCOA+ compliance, and support investigations, CAPA, method validation/transfer, and cross-functional collaboration with Manufacturing, QA,