QC Analytical Chemist

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

Position Summary

Responsible for quality, safety, and compliance of materials and products used in commercial medical device diagnostic product manufacture; performs analytical testing in a cGMP laboratory. Generates accurate, reliable data supporting product release, regulatory compliance, and uninterrupted manufacturing operations; partners with Manufacturing, QA, Supplier Quality, R&D, Engineering, and other teams.

Position Duties

• 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.

Qualifications

Required Qualifications

• Bachelor's degree required in Chemistry, Analytical Chemistry, Biology, Biochemistry, or related scientific discipline.

Preferred Qualifications

• 3+ years of QC analytical laboratory experience, including the following:
• Experience in an FDA-regulated environment.
• cGMP, GLP, GDP.
• Hands-on HPLC, FTIR, UV-Vis, and/or IC experience.
• Analytical, troubleshooting, organizational, communication skills.
• ISO 13485, SAP, TrackWise, QMS, method validation/transfer, technical writing.

Knowledge, Skills, and Abilities

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Demonstrates assertiveness and confidence in the face of a challenge.
• Effective verbal communication skills.
• Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently.
• Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity.
• Critical thinking, using logic and reason to analyze information and make decisions in the workplace.
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel, Intermediate.

Working Conditions

• Ability to remain in stationary position, either sitting or standing, for prolonged periods.
• Ability to ascend/descend stairs, ladders, ramps, and the like.
• Ability to wear PPE correctly most of the day.
• Ability to adjust or move objects up to 50 pounds in all directions.
• Must be comfortable with occasional strong smells.
• Domestic travel: 0%
• International travel: 0%

The estimated salary range for this role is between $58,700 and $88,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.

Benefits

• A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
• Company-Provided Life and Accidental Death Insurance
• Short and Long-Term Disability Insurance
• Retirement Plan including a generous non-discretionary employer contribution and employer match.
• Adoption Assistance
• Wellness Programs
• Employee Assistance Program
• Commuter Benefits
• Various voluntary benefit offerings
• Discount programs
• Parental leaves