QC Analytical Chemist — Drive QA Excellence in cGMP Lab

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

Benefits offered by this job

Medical, dental, and vision plans

Life Insurance

Disability Insurance

Retirement Plan with employer match

Adoption Assistance

Wellness Programs

Commuter Benefits

Parental leaves

Job summary

bioMérieux in Hazelwood, MO, is seeking a QC Analyst to ensure quality, safety, and regulatory compliance of materials and products used in diagnostic medical devices. The role performs analytical testing in a cGMP laboratory and supports product release and manufacturing continuity.

You will operate HPLC, FTIR, UV-Vis, IC, and related systems, review data for GDP/ALCOA+, and collaborate across QA, Manufacturing, R&D, and Engineering.

Qualifications

• Bachelor's degree in Chemistry or a related scientific discipline.
• Experience in an FDA-regulated environment is preferred.
• Experience with cGMP, GLP, GDP and GDP compliance.
• Hands-on experience with HPLC, FTIR, UV-Vis, and/or IC.
• Strong analytical, troubleshooting, organizational, and communication skills.
• ISO 13485, SAP, TrackWise, QMS, method validation/transfer, and technical writing are a plus.

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, 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.

Skills

Analytical skills

Troubleshooting

Organizational skills

Communication skills

Time management

Education

Bachelor's degree in Chemistry or related field

Tools

HPLC

FTIR

UV-Vis

IC

SAP

TrackWise

QMS

Job description

bioMérieux in Hazelwood, MO, is seeking a QC Analyst to ensure quality, safety, and regulatory compliance of materials and products used in diagnostic medical devices. The role performs analytical testing in a cGMP laboratory and supports product release and manufacturing continuity.

You will operate HPLC, FTIR, UV-Vis, IC, and related systems, review data for GDP/ALCOA+, and collaborate across QA, Manufacturing, R&D, and Engineering.