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QA Specialist - 3rd Shift Forumulation
Location:
Vernon, IN
Description:
The AstraZeneca Mt. Vernon site was established in 1972 and is the flagship site delivering innovative, life changing oral solid medicines. At the site we formulate and pack OSD tablets and capsules for over 60+ markets. The Mt Vernon site is complex, the largest AZ production site in the US with over 700+ employees. We are located in the southwest corner of the state of Indiana, approximately 15 miles from Evansville, Indiana - the third largest city in the state. The Mt. Vernon site is both collaborative and Inclusive. We have several employee resource groups (ERGs) onsite that are aimed at promoting, celebrating, and educating employees about diversity, inclusion, philanthropy, networking, etc. Each of these groups provide employees with opportunities for interactive and engaging events and initiatives which enhance professional development and provide opportunities to engage with likeminded co-workers. It is important to us that each employee feels welcome to bring their whole self to work every day. Here is a sneak peek of some of "perks" the MTV site offers: on-site fitness center with access to a personal trainer, on-site walking trail, walking desk, on-site basketball court, ping pong, massage chair, lunch & learns, sustainable & ergonomic office working environment, tuition reimbursement, training/ lifelong learning opportunities, book club, dining center with hot meals, snack market, free coffee and hot tea, climate controlled work environment. *** 3rd Shift. There are 2-3 weekends per year which require on-call QA support for production. Join us as a QA Specialist, a pivotal role within our Operations team. You will be responsible for QA activities that directly support the execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include but are not limited to: batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions. Accountabilities: As a QA Specialist, you will maintain a high level of understanding of relevant production processes and quality systems. Your role will involve QA review and approval of GMP documentation related to processing equipment and facility. You will collaborate with other Quality professionals across the organization to ensure consistent application and execution of key quality systems. You will execute QA processes including batch record review, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives. You will also stay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders. Essential Skills/Experience: - Bachelor's degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering or any Bachelor's degree with 3 years experience in pharmaceutical industry in roles covered by GMP oversight. Desirable Skills/Experience: - Excellent oral and written communication skills.- Strong ability and motivation to learn.At AstraZeneca, we champion a mindset of excellence. We believe that good can always be better and we continuously search for opportunities to add value. We harness science and evidence to foresee risk and continuously innovate to find new and better ways to improve outcomes for patients. Our work in Quality is important and valued. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We draw learnings from others, develop and understand what it takes to drive our modern mindset forward. Here you'll feel empowered to step up, follow the science and evidence to make decisions that put patients first.Are you ready to join an environment of excellence? Apply now and be part of our ambitious team! Date Posted 06-May-2024 Closing Date Our 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.
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