GMP QA Specialist: NPI, Validation & Compliance

Inteldot; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Inteldot is seeking an Administrative Shift QA professional in Puerto Rico to support the Quality Assurance program across manufacturing, process validation, regulatory compliance, and QA activities. You will review documentation, ensure GMP adherence, and participate in continuous improvement.

The role requires hands-on experience in GMP manufacturing, NPI, change control, FATs, validation, PPQs, and bilingual English/Spanish communication.

Qualifications

• GMP manufacturing experience required.
• Experience with New Products Introduction activities, Change Control, FATs, Validation, and PPQs.
• Bilingual English/Spanish communication skills.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Support QA on incident triage and CAPA records.
• Review Environmental Characterization andEMS/BMS alarms as needed.
• Represent QA on NPI team and participate in site audits.

Skills

GMP manufacturing

NPI processes

Change control

FATs & Validation

PPQs

English/Spanish bilingual

Education

Doctorate/Master's + 2 yrs OR Bachelor's +4 yrs OR Associate +8 yrs OR HS/GED +10 yrs

Job description

Inteldot is seeking an Administrative Shift QA professional in Puerto Rico to support the Quality Assurance program across manufacturing, process validation, regulatory compliance, and QA activities. You will review documentation, ensure GMP adherence, and participate in continuous improvement.

The role requires hands-on experience in GMP manufacturing, NPI, change control, FATs, validation, PPQs, and bilingual English/Spanish communication.