Senior QA Specialist — Quality & Compliance Leader

Inteldot; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Inteldot, a life sciences group with 15+ years in the field, seeks an Administrative Shift QA specialist in Puerto Rico. You will support the site QA program, review product MPs, and ensure manufacturing activities stay compliant with regulations.

The role emphasizes investigations, data analysis, and decision-making across quality systems, regulatory interactions, and process validation. Strong collaboration with Manufacturing, Validation, Regulatory, and Supply Chain is essential.

Qualifications

• Experience with quality systems, investigations and compliance assessments.
• Proficient in GMP/quality documentation and change controls.
• Capable of leading regulatory readiness and inspections.

Responsibilities

• Own site-level quality activities, including quality systems, investigations and compliance assessments.
• Investigate incidents, determine root causes and ensure effective follow-up.
• Review technical documentation to verify process and system compliance.
• Lead cross-functional teams in quality decisions and regulatory readiness.

Skills

Decision Making Techniques

Documentation Practices

Data Integrity

Change Controls

Standard Operating Procedures

Education

Doctorate + 2 years of directly related experience

Masters + 4 years of directly related experience

Bachelors + 6 years of directly related experience

Associates + 10 years of directly related experience

High school/GED + 12 years of directly related experience

Tools

KNEAT

CDOCS

SCADA

TRACKWISE

MAXIMO

Job description

Inteldot, a life sciences group with 15+ years in the field, seeks an Administrative Shift QA specialist in Puerto Rico. You will support the site QA program, review product MPs, and ensure manufacturing activities stay compliant with regulations.

The role emphasizes investigations, data analysis, and decision-making across quality systems, regulatory interactions, and process validation. Strong collaboration with Manufacturing, Validation, Regulatory, and Supply Chain is essential.