Description

Position Summary & Responsibilities:

This Quality Specialist role is responsible for supporting representation for quality related change projects, tracking risk mitigation requirements, and required project collaborations for clear communication. In this role you will be responsible for processing and tracking document revisions, change controls, departmental trending, and some system admin oversight. 

Utilization of LLDC Document System and Trackwise to process revisions and changesServe as a contact for quality related departmental projects for reagents and instruments (equipment, expansions, testing, etc.)Utilize project management tools to maintain organized records of action items Collaborate with SMEs in departments to maintain clear oversight to project requirements, impacted documents or procedures, and project costs.Support utilization of risk management skills to identify and address impacts to projects

Education, Skills, & Experience:

Bachelors degree with 3+ years of GMP experienceAssociates degree with 5+ years of GMP experience also acceptedHigh School Diploma or GED with 7+ years of progressively responsible and related GMP experience also acceptedExperience working in a FDA production environment Prior knowledge of MES, SPC, or SAP a plusStrong PC skills including proficiency in Excel, PowerPoint, Outlook, Word, Visio, and ProjectExhibits strong analytical and problem-solving skills.  Clearly expresses ideas (verbal and written) and demonstrates the ability to utilize quality system tools and techniques effectively.Strong time management skills and accountabilityFamiliarity with relevant domestic and international regulations and industry standards (e.g. ISO, FDA QSR).Strong interpersonal skills and ability to work with all levels of an organization.

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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).