Maribel - Documentation Specialist on Site Barceloneta PR

Experiencia demostrada en Document Management.

Experiencia demostrada en SOP Management.

Experiencia demostrada en Change Control Coordination.

Experiencia demostrada en Audit Support.

Experiencia demostrada en SOP Centralization.

Issued and maintained Manufacturing and Packaging Batch Records, ensuring accuracy in identification, product stage, and area documentation.. Managed the training tracking system, maintained SOP files with revision histories, and ensured timely document updates.. Supported the specification methods index and MCD documentation for laboratories, including working paper distributions.. Coordinated label control, checklists, room and equipment identification in compliance with GMP.. Assisted with the initiation of stability studies, assigning numbers and preparing documentation for annual batch evaluations.. Oversaw central file area activities, ensuring proper sorting, labeling, and retention of controlled documents.. Played a key role in regulatory inspections, contributing to audit readiness and documentation response.

Managed the plant-wide Change Control system, assigned control numbers, scheduled bi-weekly meetings, and maintained system logs and monthly reports.. Coordinated document submissions with corporate offices in New Jersey and Kalamazoo.. Supported the full SOP lifecycle including activation, deletion, distribution, and corrections.. Prepared retention reports and maintained central documentation systems aligned with compliance policies.. Provided administrative support to the Controlled Substances Department, managing regulatory correspondence with DEA and AMMSCA.. Participated in multiple external inspections, ensuring full document control and compliance support.