Sekisui Diagnostics P.E.I. Inc.
To design, create, execute and interpret analytical procedures as part of raw material qualification plans and reports under general supervision. Identifies specification requirements for raw material replacements in products for which alternate vendors or substitutions are required.
May include some or all of the following:
• Identifying raw material replacements, creating project plans for qualification of new sources of raw materials for formulations; the plan may be proceeded with planned screening experiments which are performed independently but usually will consult supervisor prior to initiation.
• Executing raw material qualifications, identifying significant findings and consulting with project team to identify path forward.
• Tracking and identifying single sourced raw materials in Sekisui formulations and for key formulations, establishing project priority levels.
• Providing analysis and justification for decision on acceptance of raw material replacements.
• Complying with all internal procedures pertaining to the development and analysis of in vitro diagnostic devices.
• Participating in activities associated with internal and external audits and regulatory inspections.
• Preparing standard operating procedures and forms required for the raw material evaluation process as required for ISO 9001 and 13485 certification.
• May supervise or train employees in performing routine established procedures.
Education / Experience:
• Bachelor of Science degree and extensive relevant work experience or MS in a scientific discipline and some relevant work experience.
Skills / Pre-requisites:
• Demonstrates working knowledge of scientific principles and techniques in the relevant scientific area.
• Experience with Word, Excel and Microsoft office.
• An understanding of diagnostic test methods and the interpretation of results as indicators of disease states.
• Experience with a variety of automated clinical chemistry analyzers.
• Abilities required to multi-task and to adapt to frequently changing market needs are essential.
• Excellent organization, time management and communication skills are essential.
• Must be capable of working independently as well as cooperatively.
• No specific training experience required.
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