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Specialist Quality Assurance at Amgen - ApplyBlast

Specialist Quality Assurance

Amgen

3 months ago

3.6 on Glassdoor

Allentown, Pennsylvania, United States

Onsite

Full Time

Senior

0 applicants

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About this role

The Specialist Quality Assurance provides critical support for the Raw Material Center warehouse in Easton, Pennsylvania, overseeing incoming raw material inspection, documentation review, and compliance with GMP, GDP, and other regulations. The role includes leading quality assessments, mentoring staff, managing logistics providers, and representing the Quality Unit during audits and regulatory interactions.

Responsibilities

Ensure operations comply with GMP, GDP, and safety regulations
Conduct sampling and inspection of incoming raw materials
Approve GMP processes and manage deviations, CAPAs, and change controls
Oversee logistics service providers and maintain service level performance
Represent the Quality Unit during audits and regulatory inspections

Skills

Qualifications

Doctorate degreeMaster's degreeBachelor's degreeAssociate's degreeHigh school diploma

About Amgen

amgen.com

Headquarters

Thousand Oaks, California, United States

Company Size

10001+ employees

Founded

1980

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Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.