Senior QA Scientist, GMP & Compliance Leader

Inteldot; Manatí (PR); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Inteldot, a life science partner with over 15 years of experience across Puerto Rico, the United States, Europe and Japan, is seeking a Senior QA Scientist to provide GMP quality oversight on the manufacturing shop floor in Puerto Rico. The role includes reviewing batch records, guiding deviations and CAPA, and supporting change control, training, and inspection readiness.

The ideal candidate will have strong cGMP knowledge, experience with TrackWise or SAP, and the ability to make risk-based

Qualifications

• 6+ years in pharmaceutical manufacturing or GMP-regulated QA roles.
• 3–5 years with quality systems: deviations, investigations, CAPA, change control.
• Knowledge of cGMP, FDA/EU GMP requirements.
• Experience reviewing GMP documentation: batch records, SOPs, reports.

Responsabilités

• Provide QA oversight of manufacturing and GMP activities on the shop floor.
• Review batch records and approve quality-related documentation.
• Lead or support deviation investigations and CAPA activities.
• Evaluate change controls for regulatory impact and product quality.
• Ensure inspection readiness across manufacturing, QC, and packaging.

Connaissances

Quality systems

Deviation investigations

CAPA management

Change Control

GMP compliance

cGMP regulations

Risk assessment

Batch record review

Quality event management

QA oversight

Formation

Bachelor’s degree in chemistry/biology/microbiology/pharmacy/engineering

Outils

TrackWise/Infinity

SAP

Microsoft Office

Description du poste

Inteldot, a life science partner with over 15 years of experience across Puerto Rico, the United States, Europe and Japan, is seeking a Senior QA Scientist to provide GMP quality oversight on the manufacturing shop floor in Puerto Rico. The role includes reviewing batch records, guiding deviations and CAPA, and supporting change control, training, and inspection readiness.

The ideal candidate will have strong cGMP knowledge, experience with TrackWise or SAP, and the ability to make risk-based