Capital Project Compliance Analyst
AstraZeneca

Job Info

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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.

Are you ready to take on a role that lets you manage GMP compliance for project activities? As a Capital Project Compliance Analyst, you will be responsible for containment plans, temporary gowning areas, coordination/inspection of capital equipment deliveries, and contractor GMP management. You will work closely with compliance, operations, maintenance, and project managers. This is your chance to learn more working at the cutting-edge and embrace constant challenges that stimulate intellectual growth!

Accountabilities:
As a Capital Project Compliance Analyst, you will manage GMP compliance for construction activities within the GMP space. You will participate in project development discussions, providing GMP guidance to assure finished project plans meet regulatory requirements. You will support the development and approval of Project Containment Plans, attend project meetings, oversee the coordination and inspection of inbound/outbound shipments for capital projects, and much more. Your role will be pivotal in maintaining site cGMP conditions adjacent to all Capital Engineering construction activities.

Essential Skills/Experience:
- Experience working in area/facility regulated by GMP
- Working knowledge of cGMP, EU, OSHA, and Environmental regulations
- Minimum of 5 years experience in maintenance, engineering, or equivalent
- High School Degree or equivalent
- Experience in pharmaceutical manufacturing
- Excellent written and oral communications skills
- Demonstrated ability to organize and implement projects that improve the operational effectiveness of a maintenance system
- Must be able to work in a fast-paced, team environment and adapt to changing business needs
- Proficient in Microsoft applications including Word, Excel, PowerPoint, and Project

Desirable Skills/Experience:
- > 5 years experience in the pharmaceutical industry
- Construction management experience
- Capital project experience

Why AstraZeneca?
With constant new products and launches, there's never been a better time to join AstraZeneca's Operations team. We are driven by the challenge to stay ahead in rapidly changing markets as we continuously seek new and better ways to deliver medicines all the way to our patients. Our resilience helps us thrive as we innovate and evolve. We foster an encouraging, positive environment where ideas are welcomed and rewarded. If you are self-driven, thrive at pace, continuously learning and proactively taking on more, then this is the place for you.

Ready to make a big impact? Join us at AstraZeneca and contribute to 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.

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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