QA Specialist: NPI, Validation & Change Control (Onsite)

Cis-International-LLC; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Amgen's Quality Assurance team in Juncos, Puerto Rico seeks a Specialist QA to support NPI, Change Control, FATs, Validation & PPQs under minimal supervision. You will review and approve MPs, validation protocols, incident triage, site audits, CAPA records, and change controls.

The role requires strong project management, cross-functional leadership, and regulatory interaction skills. The position is full-time on-site in Juncos, with a three-month initial contract and potential extension.

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.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities.
• Support facilities and environmental programs.
• Review and approve Work Orders.
• 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 leadership

Negotiation

Regulatory interaction

Data trending

Communication

Independent work

Process improvement

Team facilitation

Education

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

Job description

Amgen's Quality Assurance team in Juncos, Puerto Rico seeks a Specialist QA to support NPI, Change Control, FATs, Validation & PPQs under minimal supervision. You will review and approve MPs, validation protocols, incident triage, site audits, CAPA records, and change controls.

The role requires strong project management, cross-functional leadership, and regulatory interaction skills. The position is full-time on-site in Juncos, with a three-month initial contract and potential extension.