Quality Assurance Specialist - cGMP Compliance Partner

Amgen Inc.; Juncos (PR); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Retirement plan

Bonus program

Stock incentives

Site shutdown

Flexible work model

Job summary

Amgen Inc. in the United States seeks a Specialist QA – AML 6 to act as a key quality partner to manufacturing operations, providing oversight to ensure compliance with cGMP and Amgen quality standards.

This role supports a non-standard 12‑hour night shift and may shift with business needs; you will oversee dispositions, deviations, CAPA, change control, training, and audits, with English and Spanish bilingual communication preferred.

Qualifications

• Doctorate or equivalent degree in Life Sciences or Engineering preferred.
• Extensive QA/Manufacturing support experience required by listed levels.
• Bilingual English/Spanish is desirable for cross‑functional communication.

Responsibilities

• Execute quality disposition (approval or rejection) of bulk drug substances.
• Provide QA oversight for manufacturing, testing, storage, and distribution to ensure cGMP compliance.
• Identify, document, and manage deviations, quality events, and changes per procedures.
• Ensure production records, testing results, facilities, equipment, materials, and processes meet cGMP.

Skills

Bilingual English/Spanish

Education

Doctorate degree

Master’s degree + 2 years QA/Manufacturing

Bachelor’s degree + 4 years QA/Manufacturing

Associate’s degree + 8 years QA/Manufacturing

High school diploma + 10 years QA/Manufacturing

Tools

CDOCS

Maximo

TrackWise

LIMS

SAP

Job description

Amgen Inc. in the United States seeks a Specialist QA – AML 6 to act as a key quality partner to manufacturing operations, providing oversight to ensure compliance with cGMP and Amgen quality standards.

This role supports a non-standard 12‑hour night shift and may shift with business needs; you will oversee dispositions, deviations, CAPA, change control, training, and audits, with English and Spanish bilingual communication preferred.