Quality Specialist

Description

Position Summary

Responsible for ensuring compliance and following all regulations and quality systems within our international distribution centers. Perform time and temperature analysis for shipments within the US and LATAM distribution network. Responsible for creating quality events, obtaining dispositions, and product release for products at US distribution centers.

Primary Duties

• Evaluate shipments using Time and Temperature out of Range (TTOR) and Mean Kinetic Temperature (MKT) principles.
• Initiate quality events, liaise with manufacturing sites for dispositions and distribution centers for product release.
• Execute assigned quality projects, with guidance from technical quality expert (depending on level of experience), using engineering principles, business standards, practices, procedures, and project requirements.
• Assure proper documentation of technical data generated for the assigned projects and / or tasks consistent with applicable quality directives and procedures.
• Communicate the quality status of materials to internal customers, management, and external suppliers.
• Develop and implement departmental operational procedures to ensure regulatory compliance (FDA, GMP, ISO, OSHA, etc.).
• Make recommendations for improving quality & productivity performance.
• Contribute continuous product and process improvements in areas related to department.
• Lead activities contributing to QMS compliance : CAPA (including analysis of data and trends in complaints, nonconforming materials and root cause analysis), change control, supplier quality, internal audits, quality training, etc.
• Work with other departments to ensure operational and quality goals are understood and met.
• Participate and communicate status, business issues, and significant developments in projects.
• Develop and review procedures (both internal and external).
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Education

Qualifications

Knowledge, Skills and Abilities

Working Conditions

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BioMerieux 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 BioMerieux's or its affiliates' application process by contacting us via telephone at , by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).