Job Description Support and follow up the suppliers to ensure that quality relevant materials and services meet specifications and Company requirements.
Keep approved suppliers in compliance and document the entire process to meet the requirements of regulatory agencies and QMR03 Supplier Controls policy.
Coordinate with other areas of the Company to comply with the procedures and goals established in the area.
MAJOR RESPONSIBILITIES • Open, notify, track progress and close SCARs (supply corrective actions) to suppliers.
Approve closure of SCARS as Quality Contact in GTW system.
• Track blocked, on hold and quarantine materials to determine a material disposition to comply with the business goals or metrics.
Review and approve material disposition of non-conforming materials.
• Attend CoE of supplier metrics and supplier controls.
Escalate to management any relevant issues, corporate procedures changes and projects managed by CoE. • Support and execute activities related to assigned projects, such as assurance of supply, new product introduction, transfer products or process, sustaining and qualification of suppliers, supply change notifications, etc.
• Receive change notifications from local and international suppliers and share them with the Global GSQM department.
Lead and evaluate the change by forming an interdisciplinary team that provides support in the impact evaluation that may be generated in each of the company's departments.
• Preparation, coordination and execution of First Articles and Change Plans related to the evaluation of materials affected by change notifications or new qualifications.
• Review that material specifications for new material qualification or material changes are adequate for the incoming of the material.
• All other duties inherent to the position and those assigned by his/her immediate supervisor, including opening and actions related to deviations, NC's, CAPAS, DCC's, CCs, AIAs, CFT meetings, TRs, FSFA and internal audit responses.
Qualifications • Bachelor's degree in electrical, mechanical, electronic, electromechanical, industrial engineering, biotechnology, chemistry, computer science or related career or a combination of equivalent career experience in supplier quality roles.
• English B2 • 3 year of experience in regulated industries with expertise in supplier quality management.
• Experience as Supplier/Internal Auditor is a plus.
• Experience or certificates on electrical, mechanical, electronic, electromechanical field is a plus.
• High knowledge in root cause determination tools, such as DMAIC or A3, among others and CAPA system.
• Advanced knowledge of Office applications (Windows) • Ability to communicate written and oral ideas in a clear, concise and precise manner.
• Critical thinking and continuous improvement.
• Negotiating • Quality Management Systems/regulations (GMPs, QSR, FDA, ISO, CAPA).
Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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