QA Specialist, Quality Systems & Compliance Lead

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

Job summary

Amgen in Juncos, PR is seeking a Quality Assurance professional to support the QA program under minimal supervision. Responsibilities include reviewing MPs, approving validation protocols, leading investigations, and releasing lots for shipment.

On-site, full-time assignment with potential contract extension, expected starting October 2026 in Puerto Rico. The role requires a Bachelor’s degree in Science or Engineering with 4+ years of related experience, strong QA knowledge, and ability to work

Qualifications

• Bachelor’s degree in Science or Engineering with 4+ years of related experience in QA/Manufacturing.
• Strong knowledge of cGMP, regulatory expectations, and quality systems.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Release of sanitary utility systems.
• Lead site audits and investigations.
• Provide lot disposition and authorize lots for shipment.

Education

Bachelor’s degree in Science or Engineering + 4 years of directly related experience

Job description

Amgen in Juncos, PR is seeking a Quality Assurance professional to support the QA program under minimal supervision. Responsibilities include reviewing MPs, approving validation protocols, leading investigations, and releasing lots for shipment.

On-site, full-time assignment with potential contract extension, expected starting October 2026 in Puerto Rico. The role requires a Bachelor’s degree in Science or Engineering with 4+ years of related experience, strong QA knowledge, and ability to work