Senior QA Specialist Life Sciences, GxP & Compliance

Inteldot; Juncos (PR); On-site; USD 105,000 - 145,000; Full time

Job summary

Inteldot, a life sciences company with operations across Puerto Rico and the United States, seeks a Quality Assurance professional to support the QA program in manufacturing, process validation, regulatory compliance, and quality assurance activities.

Under minimal supervision, you will review documentation, lead investigations, support audits, and collaborate with Manufacturing, Validation, Engineering, and QA teams to ensure cGMP adherence and continuous improvement.

Qualifications

• Bachelor’s degree in science or engineering required.
• 4+ years directly related experience.
• Strong knowledge of cGMP requirements.
• Experience with QA systems and deviations/CAPA.

Responsibilities

• Review and approve QA documentation and batch records.
• Lead investigations and CAPA activities.
• Support internal/external audits and regulatory inspections.
• Collaborate across QA, Manufacturing, Validation, and Engineering.
• Ensure process validation and change controls are compliant.

Skills

Quality Assurance

Regulatory compliance

Process validation

GxP knowledge

Cross-functional collaboration

Bilingual English/Spanish

Education

Bachelor's degree in science or engineering

Tools

SAP

MES

TrackWise

EDMQ

DQMS

QMS Validation (IQ/OQ/PQ)

Job description

Inteldot, a life sciences company with operations across Puerto Rico and the United States, seeks a Quality Assurance professional to support the QA program in manufacturing, process validation, regulatory compliance, and quality assurance activities.

Under minimal supervision, you will review documentation, lead investigations, support audits, and collaborate with Manufacturing, Validation, Engineering, and QA teams to ensure cGMP adherence and continuous improvement.