Description

• Conducts routine QC testing of incoming raw material, finished goods, and stability products.
• Document results, issues, and other relevant information using good documentation practices (GDP) under the site Quality Management System.
• Reviews production batch records and QC test results for accuracy, completeness, and GDP. 
• Supports and executes protocols for analytical test methods and aids in the transfer of methods to QC.
• Perform final inspections of completed medical devices and accessories, including the detailed review of the Device History Record package to confirm the completeness and accuracy of records.
• Participates in regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of manufacturing quality. Also participates in the site Internal audit and compliance review programs.
• Supports the effective closure of complaint investigations, nonconformance reports, Cause Investigations, and CAPA in a timely manner.
• Analyzes, prepares, and communicates data findings, trends, non-conformances, and deviations.
• Maintain lab equipment compliance by ensuring preventative maintenance and calibrations are completed on time.
• Supports environmental monitoring of production spaces.
• Run instrumentation including, but not limited to UV-Vis and FTIR spectrophotometers, and microbiological diagnostic equipment.
• Maintains inventory and orders lab supplies as needed.
• Practices good lab safety according to OSHA/EHS regulations and Good Laboratory Practice (GLP), as well as other applicable regulations.
• Updates QC procedures and/or specifications as needed.
• Perform all work in compliance with company quality procedures and standards.
• Performs other duties as assigned.

• BS in biology, chemistry or related scientific field 
• Minimum of 0-1 years’ relevant laboratory experience. 
• Medical Device or other FDA regulated industry experience is preferred.
• Must possess working knowledge of good laboratory practices, GMP, and antibiotic/microorganism interactions.
• Experience working with hazardous chemicals and microorganisms.

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at recruitment@biomerieux.com.

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 recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).