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Specialist Quality Assurance – Major Deviations at Amgen - ApplyBlast

Specialist Quality Assurance – Major Deviations

Amgen

12 days ago

3.6 on Glassdoor

Juncos, Puerto Rico, United States

Onsite

Full Time

Medior

0 applicants

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About this role

The Specialist Quality Assurance – Major Deviations role serves as a quality leader responsible for investigating and resolving major deviations to safeguard product quality and patient safety. This position involves leading investigations, ensuring compliance with cGMP standards, and collaborating cross-functionally to drive effective resolutions. The role also requires utilizing approved AI tools and defending deviations during audits and regulatory inspections.

Responsibilities

Lead investigations and resolve major deviations to safeguard product quality
Review and approve cGMP documentation including deviations and procedure updates
Support regulatory inspections and audits while defending quality decisions

Skills

About Amgen

amgen.com

Headquarters

Thousand Oaks, California, United States

Company Size

10001+ employees

Founded

1980

View Profile

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