layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Specialist Quality Assurance - Major Deviations at Amgen

Let’s do this. Let’s change the world. In this vital role you will will serve as a Quality leader accountable for the investigation and resolution of major deviations, safeguarding product quality and patient safety through sound judgment, strong ownership, cross‑functional collaboration, and effective risk management in a dynamic drug product manufacturing environment.
Specific responsibilities include but are not limited to: Serve as Quality investigation lead and decision-maker for major deviations, maintaining accountability for designation, documentation quality, timeliness and closure.
Actively participate in deviation meetings, managing multiple concurrent deviations and driving effective resolution.
Provide Quality oversight to ensure thorough documentation of deviations, including floor presence, process observation, and personnel interviews across shifts.
Ensure that deviations with potential impact to product quality are properly assessed and documented per established procedures.
Verify that deviations from established procedures are investigated, documented, and resolved in accordance with Quality System requirements.
Ensure production records, laboratory results, and investigation documentation to be used as evidence for deviations are complete, accurate, and compliant with cGMP standards.
Review, approve, and track cGMP documentation, including Deviations, procedure updates and associated records.
Demonstrate strong critical thinking skills using evidence-based decision making.
Use approved AI tools, as applicable, to support major deviation activities, such as reviewing records, organizing evidence, identifying trends, and drafting investigation content. Verify AI-generated outputs for accuracy and maintain accountability for decisions and final documentation.
Collaborate cross functionally with Manufacturing, Engineering, Validation, and Quality to ensure information required is complete and accurate.
Escalate and communicate quality, compliance, supply, and patient safety risks to senior management as appropriate.
Defend deviations during internal audits, regulatory inspections, and leadership review forums. Maintain flexibility to support network interactions across time zones and operational needs requiring schedule adaptability.
Support Continuous Improvement initiatives, leveraging deviation learnings to strengthen systems and prevent recurrence.
Complete required training and perform additional duties as assigned by management.

Specialist Quality Assurance - Major Deviations

Employer job description

What you will do

What we expect of you

Basic Qualifications:

Preferred Qualifications:

What you can expect of us

About this listing

Listing check

Before you apply

Similar jobs

Similar jobs