Associate Documentation Analyst

Ensure proper operation of the Documentation Change Control Change Management Training and all in compliance with company procedures and external regulatory requirements; administer the companys 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.

Qualifications :

• Bachelors 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 EnglishSpanish Translation with strong spoken and written English and document translation capability; equivalent experience may be considered.
• Desirable: Professional Masters degree in EnglishSpanish 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: EnglishSpanish and SpanishEnglish 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).

Información adicional :

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.

Remote Work :

No

Employment Type :

Full-time