Senior QA Specialist — Validation & Compliance Expert

CIS International LLC; Juncos (PR); On-site; USD 140,000 - 210,000; Full time

Job summary

CIS International LLC is seeking a senior QA technical specialist to support Amgen's Quality Assurance program in Juncos, Puerto Rico. You will review and approve MPs, and lead investigations to ensure product quality across manufacturing and distribution.

This onsite, full-time role requires advanced degrees and extensive experience in validation, GMP compliance, and regulatory interactions. You will own site quality procedures and act as QA on incident triage and NPI teams.

Qualifications

• Doctorate or Masters with extensive QA/validation background required.
• Bachelor level with significant related experience also considered.

Responsibilities

• Review and approve MPs and environmental characterization reports.
• Lead investigations and own site quality program procedures.

Skills

Project management

Cross-functional leadership

Regulatory interaction

Data analysis

Process validation

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

Job description

CIS International LLC is seeking a senior QA technical specialist to support Amgen's Quality Assurance program in Juncos, Puerto Rico. You will review and approve MPs, and lead investigations to ensure product quality across manufacturing and distribution.

This onsite, full-time role requires advanced degrees and extensive experience in validation, GMP compliance, and regulatory interactions. You will own site quality procedures and act as QA on incident triage and NPI teams.