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Qa specialist 1

Irvine
Merck Life Science
Posted: 3 September
Offer description

Join to apply for the QA Specialist 1 role at Merck Life Science

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Join to apply for the QA Specialist 1 role at Merck Life Science

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role

We have an exciting QA Specialist position within our Irvine site. In this position, you will lead customer, regulatory, and internal audit processes, overseeing preparation, management, and final closure. You will facilitate proactive audit preparation activities with cross-functional teams, identifying and resolving risks to product quality and compliance.

As a Subject Matter Expert (SME) in Quality Assurance, you will represent our department both internally and with external customers. Your responsibilities will also include the development of procedures and the delivery of engaging onboarding and training programs related to GMP to meet regulatory requirements.

Additionally, you will be expected to identify and lead Continuous Improvement initiatives, enhancing product quality and process efficiencies to ensure the highest levels of customer satisfaction.

Who You Are


* Bachelor’s or Master’s degree, preferably in one of the biological, life, or chemical sciences.
* Minimum of five years of practical experience working within Quality Management Systems in a similar role
* 2 years GMP environment is essential.
* Practical experience in the use of Veeva Vault would be advantageous.
* Working knowledge of ISO 9001:2015 and EXCiPACT is required.
* Knowledge of cell culture products and their applications is preferred but not essential.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!


Seniority level

* Seniority level

Associate


Employment type

* Employment type

Full-time


Job function

* Job function

Quality Assurance and Science

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