QC Senior Specialist

Company: AstraZeneca

Do you have expertise in, and passion for, manufacturing in a high performing pharmaceutical environment? Would you like to apply your expertise to impact the well-being of patients in a company that follows the science and turns ideas into life changing medicines? We have future Operator opportunities in Formulation and Packaging. See below for specific responsibilities and qualifications for each group.

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost 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 for 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.

Are you ready to take your expertise in Quality Control to the next level? As a QC Senior Specialist, you'll be at the forefront of ensuring the analytical and microbiological quality control of pharmaceutical manufacturing for Mt Vernon products. You'll play a pivotal role in establishing new product introductions, analyzing raw materials, and providing analytical support for investigations within Mt Vernon Quality Control. Your responsibilities will include maintaining systems and processes within the laboratory, ensuring compliance with specifications and regulatory requirements, and executing your role with high performance to meet or exceed customer needs. You'll collaborate with others to achieve departmental objectives within budget guidelines while maintaining a safe work environment by adhering to site SHE policies and procedures.

Accountabilities

• Utilize Lean concepts to drive improvements throughout the Lab.
• Support/Lead Tech Transfer activities.
• Serve as the primary link between production and QC for investigational purposes.
• Support workflow within the QC team, understanding priorities and testing schedules.
• Verify and approve QC data while monitoring for trends and abnormalities; report and act on data results.
• Serve as QC lead for investigations involving PET process areas related to QC processes or data.
• Develop and validate new methods and processes.
• Identify and implement learning and development programs for team members.
• Provide feedback to teammates to assist with building improved performance.
• Lead and assign projects, and other ad hoc tasks and activities.
• Develop and maintain effective relationships with internal and external customers, regulators, and stakeholders.
• Facilitate and lead initiatives using new technologies, policies, or procedures to improve QC functions.

Essential Skills/Experience

• Bachelor degree in Chemistry or closely related science-based field.
• At least 3 years laboratory experience.
• Strong organizational skills.
• Strong understanding of technical areas related to lab operations (including instrumentation, statistical methods, and quality assurance).
• Ability to analyze and solve complex problems in a cross-functional team environment.
• Demonstrated ability to work with people in a complex, changing environment.

Desirable Skills/Experience

• 5 years QC laboratory experience with significant knowledge and experience in a related area, such as validation, qualification, compendial testing, analytical chemistry, and/or microbiology.
• Project management experience.
• Higher level degree.

At AstraZeneca, we are committed to pioneering a new Quality way. Here, you'll develop your expertise by being both challenged and supported to apply a modern Quality mindset. We partner with product and process experts to ensure excellence across the Quality network. Our forward-looking approach empowers you to make brave decisions that add real value throughout the lifecycle of our products. With a focus on growth and innovation, you'll have the opportunity to work on exciting products that make a real-life difference to patients.

Ready to make an impact? Apply now and join us in shaping the future of Quality Control!

Date Posted

15-Sep-2025

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.