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Job Description
Requisition ID:
Arthrex Manufacturing Inc
Ave Maria FL
Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. We are actively seeking a Chemist to join our Biological Safety Lab team at our site in Ave Maria FL. Excellent analytical skills along with Bachelor's degree in Chemistry or similar science and laboratory experience will be ideal for this position.
Main Objective:
Act as a representative of device end-users and patients ensuring appropriate maintenance of processes and procedures, at Arthrex Inc. and associated suppliers, with potential to impact the biological safety of Arthrex products.
Essential Duties and Responsibilities:
Develop and validate chemistry test methods with specific emphases on Ethylene Oxide and assessing extractables and leachables utilizing, GC/MS, and LC/MS.
Conduct and/or coordinate standardized chemical tests and laboratory analyses as necessary to evaluate the quantity and quality of physical and chemical substances found on / in manufacturing operations, environments, and devices as required by ISO 10993-7 and other International regulations.
Maintain testing and reporting quality standards in compliance with ISO/IEC 17025:2005 certifications for Arthrex laboratory testing and subcontracting activities.
Track, trend, and provide statistical analysis for testing data related to the monitoring and maintenance of manufacturing operations, and the associated special process outputs.
Enforce corporate specifications for monitoring and maintenance of production and environment standards necessary to maintain the safety of Arthrex products.
Build, maintain, and publish a database of analyzed materials, device contacting materials, and indirect contacting materials for use in development of new products and processes as well as assessment of compliance with REACH, Prop 65 and other International regulations.
Evaluate and optimize Arthrex work instructions and specifications to ensure clear and efficient communication of biological safety standards and requirements for internal and supplier based manufacturing operations.
Identify, develop, and deliver training specifically related to requirements for continued maintenance of the biological safety of medical devices and the impact of those requirements on the manufacturing processes.
Incidental Duties:
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor's degree in chemistry, material science, or similar science field required with hands on experience developing methods and maintaining gas chromatographs and liquid chromatigraphs .
Method development and validation experience, preferably in one (1) or more analytical techniques, including GC, LC strongly preferred.
Experience working in a cGMP environment with understanding of FDA requirements is a plus.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Specialized training in material and residual identification and characterization, industrial statistics, and technical writing preferred. Industry knowledge or experience with Eythlene Oxide residuals.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company).Experience with Solidworks, Minitab, and corporate ERP systems preferred.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Mathematical Skills
Ability to comprehend and - Free Classified Ads in US on Craigslist