Senior QA Associate — AML Compliance & cGMP

Amgen; Juncos (PR); On-site; USD 85,000 - 130,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental & vision

Life & disability insurance

Annual bonus

Stock-based incentives

Site shutdown

Job summary

Amgen seeks a Sr. Associate Quality Assurance AML 14 to oversee manufacturing QA and ensure adherence to cGMP and cGLP requirements. The role involves 24/7 support with non-standard schedules, including weekends and holidays, and participation in continuous improvement initiatives.

Your responsibilities include auditing, deviation investigations, batch record reviews, and system queries using Trackwise, SAP, and Veeva. Strong English communication and problem‑solving abilities are essential.

Qualifications

• 4 years of quality assurance work experience with HS/GED
• Or 2 years with Associate’s degree
• Or 6 months with Bachelor’s degree
• Master’s degree also acceptable
• Strong GMP/cGMP knowledge and documentation skills

Responsibilities

• Provide on‑site QA support to manufacturing and ensure cGMP compliance
• Monitor changes for potential impact on product quality
• Participate in internal plant audits and investigations
• Perform sampling plans and batch records reviews
• Use Trackwise, SAP, and Veeva for QA tasks
• Collaborate with operations to resolve discrepancies

Skills

Quality mindset

Problem solving

English writing/communication

Independent and collaborative work

Time management

Attention to detail

Education

Bachelor’s degree in Life Sciences or Engineering

Master’s degree

Bachelor’s degree

Associate’s degree

High school/GED

Tools

Trackwise

EBR

SAP

DQMS

LIMS

Veeva Systems

Job description

Amgen seeks a Sr. Associate Quality Assurance AML 14 to oversee manufacturing QA and ensure adherence to cGMP and cGLP requirements. The role involves 24/7 support with non-standard schedules, including weekends and holidays, and participation in continuous improvement initiatives.

Your responsibilities include auditing, deviation investigations, batch record reviews, and system queries using Trackwise, SAP, and Veeva. Strong English communication and problem‑solving abilities are essential.