Sr. Associate Quality Complaints

Sr. Associate Quality Complaints
Pharma industry
Breda
40 hours per week

Job Summary
Amgen is seeking a Quality Complaints Sr. Associate to own complaint records, supporting the Product Complaints and Surveillance Team. The Product Complaints and Surveillance team owns and executes the global complaint investigation process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

As a Sr. Associate QA Complaints, your role will involve overseeing complaint management, including conducting assessments, in accordance with Complaints Procedures and Regulatory Guidelines. Additionally, you will be tasked with establishing timelines for the completion of investigations.

Key Responsibilities:
* Initiate and own product quality complaints investigations, and safety quality investigations for Amgen commercial and/or clinical products
* Ensure complaint investigation assessments are completed accurately and on time.
* Partner with assessors from other Amgen sites and contracted suppliers/ manufacturers to resolve product complaints investigations
* Escalates potential Quality issues to Management
* Participate in site regulatory inspections of the complaint handling process and in audits (internal and third party) as required.

Basic Qualifications
Master's degree
OR
Bachelor's degree and 2 years of Quality experience
OR
Associate's degree and 6 years of Quality experience
OR
High school diploma / GED and 8 years of Quality experience

Preferred Qualifications
* Quality and manufacturing experience in biotech or pharmaceutical industry
* Bachelor's Degree in a Science Field
* Ability to successfully manage workload to timelines
* Familiarity with basic project management tools
* Demonstrated ability to consistently deliver on-time, and high-quality results
* Ability to operate in a matrixed or team environment
* Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

Let op: vacaturefraude

Helaas komt vacaturefraude steeds vaker voor. We waarschuwen je voor mogelijke misleiding:
* Wij zullen nooit via WhatsApp of in een videogesprek vragen om jouw persoonlijke gegevens (zoals een kopie van je ID, bankgegevens of BSN).
* Twijfel je over de echtheid van een vacature of contactpersoon? Neem dan altijd rechtstreeks contact met ons op via de officiële contactgegevens op onze website.

Important: job fraud

Unfortunately, job fraud is becoming more common. Beware of such scams:
* We will never ask for personal information (such as a copy of your ID, bank details, or social security number) via WhatsApp or during a video call.
* If you're unsure whether a vacancy or contact person is legitimate, please reach out to us directly using the official contact details on our website.