Primary Function/Primary Goals/Objectives:

　　The job entails working with the suppliers to provide resolve supplier quality issues as well develop and support suppliers’ continuous improvement projects.

　　Assure that investigations and continuous improvement projects associated with plant operations conform to its requirements and risk assessment, Abbott Nutrition Quality standards and other applicable regulatory standards.

　　Develop and support continuous improvement projects to improve incoming lab efficiencies.

　　Major Responsibilities:

　　Lead investigations to resolve and troubleshoot supplier events including processing or packaging issues.

　　Write up of exception reports related to supplier issues.

　　Responsible to resolve and approval of exception reports within the plants.

　　Monitor ingredients and packaging events (SENs and Exception Reports) monthly and quarterly and identify and resolve trends.

　　Identify continuous improvement with vendors to drive towards zero supplier quality events.

　　To ensure that proper incoming material documentation involving CAPA and specifications are compliant to Corporate and regulatory requirements.

　　Drives improvement and corrective action in the quality of incoming raw materials, and packaging materials.

　　Provides technical support in the selection of suppliers.

　　Responsible for site new suppliers’ qualification and ensure the timeline are kept.

　　Work with technical SME to develop acceptance criteria for materials.

　　Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

　　Develop and approve site suppliers’ material acceptance program.

　　Lead supplier audits for material qualification as well as to support Division supplier QA for surveillance audits and new qualification for materials.

　　Work with Division supplier QA on ingredients and packaging suppliers’ systems and processes to improve process capability and to develop certificates of analysis where applicable.

　　Assure appropriate supplier in-line equipment is validated.

　　Maintain relevant documentation such as suppliers’ policies, procedures, specifications, and acceptance programs and assure these documents are current and compliant to internal policies and regulations.

　　Develop and Approve site suppliers’ material acceptance program.

　　Assure that proposed changes made to supplier processes are approved and compliant to specifications, making changes when necessary.

　　Manage ingredients and packaging supplier recurring CAPAs on a monthly, quarterly and annual basis by evaluating exception report data and reporting information to appropriate areas of the business (i.e. Purchasing and Operations), as well as the suppliers.

　　Drive continuous improvement projects to improve efficiency and cost savings related to materials (ingredients & packaging).

　　Support site Quality compliance activities where needed. Examples: monthly GMP walkdown audits and site IQA program, etc.

　　Any other duties as assigned by supervisor.

　　Skills/Experience Requirements:

　　3 to 5 years of experience in supplier quality assurance programs or related experience in operations, or quality assurance.

　　Excellent collaboration skills, communication skills, problem solving competence, organizational skills, training skills and budget management should be demonstrable.

　　Good practical knowledge of GMP in food/ pharmaceutical manufacturing.

　　Education:

　　Bachelor’s degree, in the field of engineering, food science, food technology, nutrition, chemistry, or related discipline.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]