Senior QA Specialist - Validation & Investigations Lead

CIS International LLC; Juncos (PR); On-site; USD 90,000 - 150,000; Full time

Job summary

CIS International LLC in Juncos, PR is seeking a senior QA professional to support Amgen's Quality Assurance program. The role focuses on reviewing and approving MPs, process validation, and leading investigations to ensure product quality and regulatory compliance.

You will represent QA on incident triage, NPI teams, and site quality programs, with on-site responsibilities and potential overtime. This is a full-time, 12-month project with possible extension based on performance.

Qualifications

• Requires advanced degree with directly related experience as listed.
• Experience in commissioning and qualification, equipment validation, QRAES, Kneat, GxP documentation.
• Knowledge of Change Controls, SOPs, and Good Documentation Practices.

Responsibilities

• Approve process validation protocols and reports for manufacturing processes.
• Represent QA on incident triage and NPI teams.
• Approve Environmental Characterization reports and sanitary utility releases.
• Lead investigations and owner of site quality program procedures.
• Designee for QA manager on local CCRB.
• Coordinate with regulatory agencies as needed.

Skills

Project management

Cross functional teamwork

Leadership & negotiation

Regulatory interaction

Document control & data analysis

Independent work

Education

Doctorate + 2 years exp

Masters + 4 years exp

Bachelors + 6 years exp

Associates + 10 years exp

High school/GED + 12 years exp

Job description

CIS International LLC in Juncos, PR is seeking a senior QA professional to support Amgen's Quality Assurance program. The role focuses on reviewing and approving MPs, process validation, and leading investigations to ensure product quality and regulatory compliance.

You will represent QA on incident triage, NPI teams, and site quality programs, with on-site responsibilities and potential overtime. This is a full-time, 12-month project with possible extension based on performance.