Ensure proper operation of the Documentation Change Control, Change Management, Training, and all in compliance with company procedures and external regulatory requirements; administer the company’s training system and controlled-document storage system.
MAJOR RESPONSIBILITIES
• Administer the company training system: create, assign, modify, and delete curricula and items; accredit in-person training; generate reports; and address system inquiries.
• Administer the Change Control Board, including training, record review and follow-up, conducting meetings, and updating the board.
• Support audits and actions assigned to the department.
• Generate required metrics, including training and change control metrics.
• Administer the electronic documentation system, including folder creation and organization, related training, and reporting.
• Administer the DCC process (review, follow-up, translation, and release); support inquiries on DCC creation and training; and make required SAP (ECR) modifications when needed.
• Support other areas with document translation.
Perform other duties inherent to the role and assigned by the manager.
• Bachelor’s degree in Engineering field, Business Administration, or STEM career with strong spoken and written English and document translation capability (equivalent experience may be considered) OR
• English Language Teaching, English, English–Spanish Translation with strong spoken and written English and document translation capability; equivalent experience may be considered.
• Desirable: Professional Master’s degree in English–Spanish Translation or C1 English Level
• Desirable: Six Sigma Green Belt, Power BI or equivalent.
• Up to 1 year of experience in a highly regulated industry, desirable medical devices industry.
• Documentation Center Clerk or Documentation Analyst experience highly preferred.
• Focus on excellence and detail oriented.
• Adaptability, communication, continuous improvement, customer service orientation.
• Quality Management Systems knowledge: GMPs, QSR, ISO, and CAPA; prior participation in quality audits, preferably FDA or ISO certification-body audits.
• Required: English–Spanish and Spanish–English translation experience; customer service; high proficiency in Spanish and English; and Windows-environment software proficiency.
• Knowledge of communication techniques and effective time management. Desirable: Visio, AutoCAD, SAP, Arena, Windchill, Veeva, Salesforce systems knowledge (or any other documentation system repository or PLM system)
• Ability to communicate with stakeholders across organizations and understand technical requirements (SOPs, DMR, DHR, DRW).
AbbVie es un empleador que ofrece igualdad de oportunidades y se compromete a operar con integridad, impulsar la innovación, transformar vidas y servir a nuestra comunidad. Empleador que ofrece igualdad de oportunidades, veteranos y discapacitados.