QC Analytical Chemist – cGMP Med Device Lab

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

Benefits offered by this job

Medical, dental, and vision coverage

Retirement plan with company match

Life and disability insurance

Paid time off and holidays

Wellness program

Job summary

bioMérieux is seeking a Quality Control/Lab Analyst in Hazelwood, MO to ensure material and product quality for medical device diagnostics. You will perform analytical testing, operate HPLC, FTIR, UV-Vis and IC systems, and ensure GDP/ALCOA+ data integrity in a GMP environment.

The role requires a Bachelor's in a chemistry-related field and 3+ years of QC experience in FDA-regulated settings. Knowledge of ISO 13485 and TrackWise is preferred.

Qualifications

• Bachelor's degree required in Chemistry, Analytical Chemistry, Biology, Biochemistry, or related scientific discipline.
• 3+ years of QC analytical laboratory experience preferred in FDA-regulated environments; cGMP/GLP, GDP experience.
• Hands-on experience with HPLC, FTIR, UV-Vis and/or IC.
• Analytical, troubleshooting, organizational and communication skills.
• ISO 13485, SAP, TrackWise, QMS, method validation/transfer, technical writing preferred.

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

MS Office proficiency

Education

Bachelor's degree in Chemistry or related

Tools

HPLC

FTIR

UV-Vis

IC

QMS software (TrackWise, SAP)

Job description

bioMérieux is seeking a Quality Control/Lab Analyst in Hazelwood, MO to ensure material and product quality for medical device diagnostics. You will perform analytical testing, operate HPLC, FTIR, UV-Vis and IC systems, and ensure GDP/ALCOA+ data integrity in a GMP environment.

The role requires a Bachelor's in a chemistry-related field and 3+ years of QC experience in FDA-regulated settings. Knowledge of ISO 13485 and TrackWise is preferred.