QA Specialist - Mt Vernon - Global Operations
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.
The 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, capsules, powders and liquids to over 60+ markets. The Mt Vernon site is the largest AZ production site in the US and is located in the southwest corner of the state of Indiana, approximately 15 miles from Evansville, Indiana – the third largest city in the state of Indiana. The Mt. Vernon site is dedicated to creating a culture of inclusion and collaboration. We host yearly Inclusion and Diversity conferences and have an employee resource group devoted to promoting diversity and inclusion and enhancing employees' professional development through interactive and engaging events and initiatives.
The QA Specialist is responsible for QA activities that directly support 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.
This position will be a Straight 2nd Shift position.
What you’ll do:
- Maintains a high level of understanding of relevant production processes and quality systems.
- Performs the QA review and approval of the following GMP documentation as it relates to the processing equipment and facility to which the position is aligned: Change Requests, Batch Records and associated documentation, Product and Component Release transactions in SAP, Quality Investigations (Deviations, Product Complaints), Validation Plans, Protocols, and Reports and Standard Operating Procedures
- Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems.
- Executes QA processes including batch record review, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives.
- Works with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensures GMP compliance during the planning, execution, and closeout phases of these projects.
- Collaborates with and influences other PET/assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices.
- Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders and collaborates in data analysis and report creation on quality metrics and key performance indicators.
Essential for the role:
- Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering or any Bachelor’s degree with 3 years proven experience in pharmaceutical industry in roles covered by GMP oversight.
- Excellent oral and written communication skills.
- Strong ability and motivation to learn.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being ambitious - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!
Next Steps – Apply today!
To be considered for this great opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be an excellent fit, please share this posting with them.
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 authorisation and employment eligibility verification requirements.