QC Document Specialist/Reviewer

Job Title: QC Document Specialist/ReviewerPay Rate: $33.65/HrDuration: 12 monthsLocation: Elkhart, INThis position is for the Healthcare Diagnostics division.We are looking for a QC Document Specialist/Reviewer for a manufacturing group that produces components for in-vitro diagnostic assays. Focus on record review and control, document change control, and equipment management.Management of document control systems, including review of documents and processing changesManage quality record archivesPerform a final review of device history records (DHRs) at a high level of detailPerform batch disposition in the SAP systemMaintain metrics for batch records and document control systems as applicableReview equipment service records, including updating information in the electronic equipment management systemReview validation documentation for successful completion and GDPSupport of other Quality Assurance responsibilities as neededRequirements:BS in Life Science or equivalent experienceMinimum Office Suite, some technical writing skills, SAP or MRP planningDocumentation practices and customer service skills are neededApplicants with experience in a GMP/ISO-regulated environment are preferred.Applicant should be familiar with Good Documentation Practices.Demonstrated exceptional attention to detail and a professional demeanor.Preferred Knowledge/Skills, Education, Experience:Experience in a regulated environment (21 CFR 820 and/or ISO 13485)Equipment validation and service management (CAL/PM)Technical writingSAP Quality Management experience