QC Analytical Chemist

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%

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BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).