Compliance Engineer

Flexible & Integrated Technical Services, LLC•Gurabo, PR

3d•Onsite

About The Position

For Compliance, Engineering and Quality Services. This role involves managing investigations and CAPA, monitoring GMP metrics, and revising documents. The ideal candidate will have a Bachelor's degree in Engineering with over five years of experience in compliance and quality within the pharmaceutical industry. Bilingual in Spanish and English is required. The position operates on an administrative shift according to business needs.

Requirements

Bachelor’s degree in Engineering
Over five (5+) years of exposure in the Compliance and Quality activities within the Pharmaceutical industry.
Bilingual, Spanish and English.

Nice To Haves

Treats everyone they meet like family, especially our resources, clients and team members.
Customer service pro.
Full of bright ideas and eager to innovate.
Always bringing top-quality results to the table.

Responsibilities

Manage investigations and CAPA from the Project Execution team and Site Engineering team as required.
Monitor GMP metrics such as Training, Change control on time closure, CAPA on time closure.
Revise documents in TV and Kneat.
Conduct GMP review of documentation.
Write, evaluate, and revise the required manufacturing documentation (SOP’s, MBR’s, etc.) and assist in providing training on scientific or technical aspects of the processes.
Responsible for executing Corrective Action Preventive Action (CAPA’s), procedures development & revision, and process validation documentation.
Act as facilitator for the necessary information related to the support of the existing processes and the fast tracking for documenting and implementing process modifications.