MAIN RESPONSIBILITIES

　　• Lead QC organization with 2030 associates to ensure product quality control is done according to the standard.

　　• Review & approval of QC result of Biologics, Semi-finished goods & final products of rapid test, ELISA assay and Urine analysis

　　• Review and approve Verification & Validation of Incoming Materials

　　• Review the validation and verification test for process and stability testing

　　• QC standard material (Panel) management

　　• Manage of Inspection/Audit and CAPA review and approval

　　• Transfer test method technology

　　• Review & approval

　　• Review and manage of QC Budget

　　QUALIFICATIONS

　　Education

　　Over bachelor degree in relevant major (Knowledge on diagnosis mechanism (Biological, Immunization)

　　Experience/Background

　　• Leadership experience in QC (> 10 years) in bioi ndustry , medical device or IVD

　　• Experience in leadership role in organization more than 10 HC

　　• Exceptional Communication skill in English (in technical writing and conversation)

　　• Exceptional communication skills and ability to facilitate cross-functional cooperation

　　• Knowledge on GMP & ISO / Regulatory guidelines

　　• Compressive knowledge Validation, Verification, Stability, Risk assessment, CAPA and change control process based on ISO 13485:2016

　　• Global inspection experiences

　　Preferred whom with

　　• Proven leadership capability

　　• Work experience in global company

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]