QA Specialist – NPI, Validation & Change Control

CIS International LLC; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

CIS International LLC seeks a Specialist QA for on-site work in Juncos, PR. The role supports Amgen's QA program with responsibilities spanning NPI, change control, FATs, validation, PPQs, incident triage, and regulatory interactions.

The position is full-time with a potential extension based on performance and budget. Ideal candidates hold advanced degrees with substantial related experience and strong leadership in cross-functional teams, investigations, and quality systems.

Qualifications

• Doctorate or Masters with related experience required.
• Bachelor’s + 4 years related experience required.
• Associates + 8 years related experience or equivalent.
• High school/GED + 10 years related experience acceptable.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Lead investigations and site audits.
• Own site quality program procedures.
• Review and approve change controls and CAPA records.
• Provide lot disposition and authorize lots for shipment.

Skills

Project management

Cross-functional collaboration

Regulatory interaction

Investigation leadership

Documentation and recordkeeping

Attention to detail

Education

Doctorate or Masters + 2 years related experience

Bachelors + 4 years related experience

Associates + 8 years related experience

High school/GED + 10 years related experience

Tools

MS Word

MS Excel

Electronic Quality Systems

Job description

CIS International LLC seeks a Specialist QA for on-site work in Juncos, PR. The role supports Amgen's QA program with responsibilities spanning NPI, change control, FATs, validation, PPQs, incident triage, and regulatory interactions.

The position is full-time with a potential extension based on performance and budget. Ideal candidates hold advanced degrees with substantial related experience and strong leadership in cross-functional teams, investigations, and quality systems.