Senior QA Specialist: GMP, CAPA & Investigations Lead

CIS International LLC; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Amgen in Juncos, Puerto Rico is seeking a Quality Assurance professional to support the QA program under minimal supervision. Responsibilities include reviewing and approving MPs, validation protocols, environmental reports, and lot disposition, while representing QA on NPI teams and leading investigations.

This on-site role emphasizes collaboration with Manufacturing, Engineering, and Process Development, with a focus on GMP, GDP, and electronic quality systems.

Qualifications

• Doctorate or Masters + 2 years of directly related experience.
• Bachelors + 4 years of directly related experience.
• Associates + 8 years of directly related experience.
• High school/GED + 10 years of directly related experience.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

Skills

Project management

Organizational skills

Cross-functional teamwork

Negotiation

Regulatory interaction

Documentation

QA processes

GMP knowledge

GDP knowledge

Electronic quality systems

Data trending

Communication

Education

Doctorate + 2 years experience

Bachelor + 4 years experience

Associates + 8 years experience

High school/GED + 10 years experience

Job description

Amgen in Juncos, Puerto Rico is seeking a Quality Assurance professional to support the QA program under minimal supervision. Responsibilities include reviewing and approving MPs, validation protocols, environmental reports, and lot disposition, while representing QA on NPI teams and leading investigations.

This on-site role emphasizes collaboration with Manufacturing, Engineering, and Process Development, with a focus on GMP, GDP, and electronic quality systems.