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Quality Engineer Specialist, Quality Risk Management

1 month ago

Rockville, United States AstraZeneca Full time
Job Description

Introduction to role:

Join our dynamic Operations team as a Quality Engineer Specialist in Quality Risk Management. In this role, you will provide in-depth understanding and application of pharmaceutical quality risk management practices and approaches in design and manufacturing environments. You will have the opportunity to demonstrate intimate working knowledge of pharmaceutical relevant standards, principles and best practices. This is a chance to work on diversified tasks with a global team, and be exposed to new ways of thinking, helping us to grow collectively and as individuals.

Accountabilities:

As a Quality Engineer Specialist, you will facilitate and guide cross-functional team members in the use of available quality risk management tools, including FMEA, PHA, RR&F. You will collaborate with project teams and necessary departments to complete risk assessments and lead teams in identifying mitigations. You will evaluate product data for their impact on the current quality risk management files and author and review quality risk management plans, reports, and risk assessments. You will also ensure that all AstraZeneca policy and procedures for the Risk Management Program are followed at the site level.

Essential Skills/Experience:

- Bachelor’s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 2 years of experience in a pharmaceutical or FDA regulated environment.

- Familiarity with global regulatory agencies’ requirements for Quality Risk Management and Quality Systems (ICH Q9, GAMP5, 21CFR 11/210/211)

- Ability to prioritize, manage and follow-up on numerous projects and activities

- Effective written and verbal communication skills

- Excellent technical writing experience in a regulatory environment

- Detail oriented and exhibit a high degree of flexibility and initiative

- Ability to function efficiently in a diverse, fast paced, changing environment

- Ability to work independently as well as part of a team

- Ability to think critically, and utilize troubleshooting and problem solving skills

Desired Skills/Experience:

- Masters degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field)

- Cell and Gene Therapy experience is a plus

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we take Quality seriously. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. Our focus is on scaling and introducing new technologies, using models to predict and proactively manage risk. We are strong communicators and networkers, working together as a team to get our pipeline out to patients sustainably, reliably and safely. We follow evidence to reach outcomes that benefit patients and AstraZeneca. It's an inclusive and friendly community here where each voice matters.

Ready to make a difference? Apply today

Date Posted

25-Jul-2024

Closing Date

07-Aug-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.