Documentation Clerk Part Time - Gurabo

Descripción del Empleo:
Responsible of maintaining control filing of the Quality Assurance Regulatory Compliance Documentation Area, ensuring the conformance of the current Good Manufacturing Practices, JSC and J&J policies, and internal procedures. Maintains a database for the documentation in the area, provides in a timely manner documentation requested during regulatory/internal inspections, in support of internal investigations and/or studies. Responsible for the proper filling and storage of all documentation delivered to the area such as Manufacturing & Packaging Batch Records, Incoming Area Records, Validation Protocols & Reports, NDAs/DMFs, Annual Product Review, Cleaning log books, and basically all documents related with product disposition and other QA/RC Documentation. Responsible to digitalize all regulatory documentation using AQUARIUS system.
Requisitos:
Bachelor's Degree in Science or related field. Minimum of two years of experience in pharmaceutical industry or related preferably with knowledge of c'GMPs and compliance aspects.
Fluent in Spanish and English and excellent ability to write in English and Spanish. Good written and oral communication skills
Proficient in the use of MS Office applications Word, Excel, Power Point, Outlook , eLIMS and SAP. Data entry skills into Excel spread sheets and/or Microsoft Word .
Good data analysis and customer service orientation
Available part time position : L-V 1pm- 6pm/ 12pm- 5pm