Clinical Outcomes Analyst, Sr. jobs in Pennsylvania

Accountabilities:

Are you ready to serve as the primary investigator for deviation events, support OOS investigations in manufacturing, and build CAPAs? Can you handle and increase the effectiveness and efficiency of manufacturing operations through improvements via a reduction of deviations, documentation errors, and hold up of batch records? Are you prepared to ensure all assigned projects and deliverables (i.e. corrective actions, deviations, kaizen action items, CAPA, etc…) are completed per commitment date? Are you excited to drive initiatives in the manufacturing operations that contribute to a long-term operational excellence culture? If so, this role is for you!

Essential Skills/Experience:

- BS Degree in engineering, science, or equivalent

- Minimum of five (5) years of manufacturing, quality, and/or FDA regulatory experience.

- Relevant knowledge of cGMP, lean principles, and regulatory requirements.

Desirable Skills/Experience:

- Green belt preferred. Strong consideration will be given to candidates with previous aseptic processing experience in the bio/pharmaceutical industry. Competent in the delivery of interpersonal and analytical skills.

- Minimum of seven (7) years of manufacturing, quality, and/or FDA regulatory experience) preferred

- Minimum of three years of shown manufacturing, quality, and/or FDA compliance investigatory writing experience

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, the entire shift at the facility. 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.

Why AstraZeneca?

With constant new products and launches, there's never been a better time to join Supply Chain and craft our future with a big contribution to life-changing medicines. The challenge to stay ahead in dynamic markets is what keeps us driving forward, as we continuously seek new and better ways to deliver medicines all the way to our patients. Our resilience helps us to thrive as we innovate and evolve. Ours is a safe and positive space. Here we are encouraged to actively participate by sharing ideas, and problem-solving. United behind a common goal to succeed, we take our collective learnings and work as a team to keep pushing the boundaries of Supply Chain.

Ready to make a big impact? Apply now and join us in our mission to create life-changing medicines!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.