Regulatory Compliance Officer

Flexible & Integrated Technical Services, LLC•Arecibo, PR

1d•Onsite

About The Position

This role is within the Compliance Services QA area. The ideal candidate will have a Bachelor's Degree with three (3) years of experience in the pharmaceutical or regulated industry. Bilingual (English & Spanish) skills and Project Management experience are required. The shift is administrative and will adjust according to business needs. The position requires experience in compliance with regulations, Quality Systems (including Deviations, CAPA, and Change Control), and familiarity with documentation platforms such as CDOCS, Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP. The role is suited for someone who thrives in a lab environment, possesses multitasking, scientific, and creative skills, and values healthy competition, teamwork, ethics, and the scientific method.

Requirements

Bachelor's Degree
Three (3) years of experience within the pharmaceutical or regulated industry
Bilingual (English & Spanish)
Project Management skills
Experience in Compliance to regulations
Experience in Quality Systems, including Deviations (Nonconformities), CAPA, and Change Control
Experience with Documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP

Responsibilities

Facilitation/execution of the internal/external inspection process.
Generation and tracking of reports/information related to inspection activities.
Performing checks/verifications of improvements and commitments resulting from inspection activities.
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.