2nd Shift QA Specialist — Raw Materials & Logistics

Amgen; Allentown (Lehigh County); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work models

Job summary

Amgen in Easton, Pennsylvania seeks a Specialist Quality Assurance to support the Raw Material Center (RMC) warehouse on the 2nd shift. The role emphasizes regulatory compliance, materials sampling, and documentation review to ensure a robust quality system.

The candidate will lead QA activities, approve GMP processes, manage deviations and CAPAs, and collaborate with logistics providers and internal teams to sustain product quality and supply chain integrity.

Qualifications

• Basic Qualifications require Doctorate, or Master’s with 2+ years QA experience, or Bachelor’s with 4+ years QA experience, or Associate’s with 8+ years QA experience, or HS diploma with 10+ years QA experience.
• QA experience and knowledge of GMP, GDP, and quality systems are essential.
• Ability to lead, train staff, and coordinate with regulatory bodies.

Responsibilities

• Ensure operations comply with GMP, GDP, GMP recordkeeping requirements.
• Conduct sampling and inspection of incoming raw materials and assess documentation.
• Review receipt, storage, and distribution documentation and records.
• Approve GMP processes, deviations, CAPAs, and change controls.
• Provide QA oversight and lead staff, training, and mentorship.

Skills

Continuous Improvement/Process Optim

AI savvy

Cross-functional communication

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Veeva

SM LIMS

ERP systems

Job description

Amgen in Easton, Pennsylvania seeks a Specialist Quality Assurance to support the Raw Material Center (RMC) warehouse on the 2nd shift. The role emphasizes regulatory compliance, materials sampling, and documentation review to ensure a robust quality system.

The candidate will lead QA activities, approve GMP processes, manage deviations and CAPAs, and collaborate with logistics providers and internal teams to sustain product quality and supply chain integrity.