Senior QA Associate – AML Compliance & Quality Assurance

Amgen SA; Juncos (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

Amgen is seeking a Sr. Associate Quality Assurance AML 14 to support on-site QA across manufacturing areas, ensuring compliance with cGMP/cGLP. You will participate in investigations, batch reviews, and deviations handling while working with Trackwise, SAP, DQMS, and LIMS systems. Strong technical writing and English communication are essential.

The role emphasizes the ability to work non-standard schedules and collaborate with cross-functional teams to deliver high-quality products for patients.

Qualifications

• High school/GED with 4 years QA experience or equivalent.
• Bachelor’s or Master’s degree with QA exposure as listed in qualifications.
• Experience with Trackwise, EBR, SAP, DQMS, LIMS and Veeva Systems.
• Fluent English; bilingual (English/Spanish) preferred.

Responsibilities

• Provide on-site QA oversight to ensure cGMP, cGLP compliance across manufacturing and testing activities.
• Ensure deviations, investigations, and changes are documented per procedures.
• Support batch records review, sampling plans, Trackwise, SAP, and Veeva system queries.
• Participate in internal plant audits and investigations.
• Maintain strong technical writing and communication to ensure quality records.

Skills

Quality Assurance

cGMP knowledge

Technical writing

English proficiency

Communication skills

Problem-solving

Education

High school/GED + 4 years QA experience

Associate’s + 2 years QA experience

Bachelor’s + 6 months QA experience

Master's Degree

Tools

Trackwise

EBR

SAP

DQMS

LIMS

Veeva Systems

Job description

Amgen is seeking a Sr. Associate Quality Assurance AML 14 to support on-site QA across manufacturing areas, ensuring compliance with cGMP/cGLP. You will participate in investigations, batch reviews, and deviations handling while working with Trackwise, SAP, DQMS, and LIMS systems. Strong technical writing and English communication are essential.

The role emphasizes the ability to work non-standard schedules and collaborate with cross-functional teams to deliver high-quality products for patients.