Quality Engineer 1 SIMNJP00071573

Description This position will cover Laboratory Diagnostic Manufacturing. The primary roles of this individual are to provide audit support and inventory reporting to meet work-center demands. This role encompasses the support and coordination of batch record/DHR audits in the Reagent Manufacturing area and Chromatography Manufacturing area. The core competencies that are essential to success are attention to detail and organization. Additionally critical thinking, with a solid understanding of quality implications, is necessary in managing audits efficiently and compliantly through manufacturing. Communication is needed to maintain visibility of the audit and progress of the product The scope of this role includes review of manufacturing batch records to verify compliance requirements are met, verify results to specifications, and verify materials used. Additionally this role will report materials used in the inventory management system and assist with inventory investigations. This position may occasionally require weekend coverage (Saturday or Sunday) if required by the Operations schedule Required Education, Skills & Experience: Ability to provide guidance and leadership, strong communication skills, organization A high level of attention to detailed processes Preferred Experience: A background in SAP is a plus. Education: BS/BA in related discipline, or equivalent combination of education and experience. Knowledge and Experience: Demonstrates a basic knowledge of professional principles and skills. Effectively uses fundamental concepts, practices, and procedures of particular area of specialization. Typically, up to 2 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable.