QC Analytical Chemist

bioMérieux • Hazelwood, MO

4d • $58,700 - $88,000

About The Position

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 and 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.

Requirements

• Bachelor's degree in Chemistry, Analytical Chemistry, Biology, Biochemistry, or a related scientific discipline.
• Analytical, troubleshooting, organizational, and communication skills.
• Effective verbal communication skills.
• Time-management skills to allocate tasks, balance priorities, and meet deadlines efficiently.
• Ability to manage tasks, multitask, and adapt quickly in a fast-paced environment.
• Critical-thinking skills, using logic and reason to analyze information and make workplace decisions.
• Intermediate skill with MS Office tools, including Outlook, Teams, Word, and Excel.
• Ability to remain stationary, sitting or standing, for prolonged periods.
• Ability to ascend and descend stairs, ladders, ramps, and similar structures.
• Ability to wear PPE correctly most of the day.
• Ability to adjust or move objects weighing up to 50 pounds in all directions.
• Comfort with occasional strong smells.

Nice To Haves

• 3+ years of QC analytical laboratory experience.
• Experience in an FDA-regulated environment.
• Knowledge of cGMP, GLP, and GDP.
• Hands-on experience with HPLC, FTIR, UV-Vis, and/or IC.
• Knowledge of ISO 13485, SAP, TrackWise, and QMS.
• Experience with method validation and transfer.
• Technical writing skills.

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.

Benefits

• Variable annual bonus based on company, team, and individual performance.
• Choice of medical, prescription, dental, and vision plans with nationwide coverage and telemedicine options.
• Company-provided life and accidental death insurance.
• Short- and long-term disability insurance.
• Retirement plan with a non-discretionary employer contribution and employer match.
• Adoption assistance.
• Wellness programs.
• Employee Assistance Program.
• Commuter benefits.
• Various voluntary benefit offerings.
• Discount programs.
• Parental leaves.

What This Job Offers

• Job Type: Full-time