Associate Documentation Analyst

Sobre la empresa

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at http://www.abbvie.com/. Follow @abbvie on LinkedIn,Facebook, Instagram, X and YouTube.

Tareas

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.

Requisitos

• 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).

Otros

Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.