QC Analytical Chemist

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%

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