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 exceptional 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.

We are a team of results-oriented people, who want to go far, and we’re all here to achieve. It’s what drives us to be proactive and solutions-focused. At every stage of production, we step up and take accountability to deliver, each of us feeling responsible for the outcomes. What we do is important and valued – we make a real-life difference to patients.

The Senior Quality Systems Specialist / Quality Systems Specialist is responsible for Quality System activities that directly support execution of the process both within the Process Execution Team (PET) and Quality Control. These activities may include but are not limited to Quality Systems supporting: batch release, change control and documentation, flavour management, equipment and process validation, deviation investigations, SOPs, and supplier management.

This position could be either a Senior Quality Systems Specialist or Quality Systems Specialist depending on experience.

What you’ll do:

Senior Quality Systems Specialist

• Subject Matter Expert (SME) for SAP Quality processes and other quality systems (e.g., GQCLims). Leads, collaborates with, and influences other Quality professionals within and outside of the organization to ensure consistent application and execution of key quality processes, including flavour management.
• Develops and executes QA master data processes which impact batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives.
• Leads site support groups (e.g., IT) and proactively ensures GMP compliance related to Quality Systems. Coordinates and executes development activities for key Quality Systems such as SAP. Leads, collaborates with, and influences other assigned area members to facilitate process improvements; benchmarks internal and external QA master data practices to identify innovative efficient and effective practices.
• Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders. Serves as a site primary point of contact for AZ Regulatory (CMC-RC) interactions. Authors Regulatory documents. Leads and coordinates site projects/requests for Health Authority submissions.
• Establishes and maintains appropriate training curricula for the role, along with the Master Data Analyst roles. Initiates area change proposals as required.
• Participates in the identification, investigation, and correction of Processing-related issues. Resolves operational and technical issues through effective communication with support departments.

Quality Systems Specialist

• Maintains a high level of understanding of relevant production system processes (e.g., SAP) and quality systems (e.g., GQCLims, Empower, MODA, LES,...). Leads, collaborates with, and influences other Quality professionals across the organization to ensure consistent application and execution of key quality system master data.
• Develops and executes QA master data processes which impact batch record review, QC testing, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives.
• Collaborate with site support groups (e.g., IT) and proactively ensures GMP compliance related to master data. Leads, collaborates with, and influences other assigned area members to facilitate process improvements; benchmarks internal and external QA master data practices to identify innovative efficient and effective practices.
• Processes cGMP documents in complex, automated document management systems such as LDMS (Light Document Management System). Coordinates review and approval of documentation by subject matter experts.

Sr Quality Systems Specialist

Required:

• Bachelor’s degree in a Science/technical field such as Pharmacy, Biology, Chemistry or Engineering or any Bachelor’s degree with 5-10 years’ experience in pharmaceutical industry in roles covered by GMP oversight.
• Excellent oral and written communication skills. Strong ability and motivation to learn.
• Must have proven ability to plan, implement, and achieve significant, complex goals and objectives. Demonstrated ability to collect, communicate, and present data and information.
• Demonstrated ability to prioritize tasks; data collection requirements across several product lines will require good time management skills.
• Ability to interact with employees at multiple levels of the organization with varying levels of process knowledge.

Quality Systems Specialist

Required:

• Associates degree in a Science/technical field such as Pharmacy, Biology, Chemistry or Engineering AND 3 years’ experience in pharmaceutical industry in roles covered by GMP oversight, or 10+ years’ experience within Quality Assurance in the Pharmaceutical industry.
• 3 years’ experience in electronic document management, data management, laboratory, or MRP systems.
• Excellent oral and written communication skills. Strong ability and motivation to learn.

Preferred:

• Bachelor’s degree, preferably in a Science/technical field.

Why AstraZeneca?

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 entrepreneurial - 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.

Date Posted

Closing Date

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.