QC Information Systems – Senior Specialist

Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe.  We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building functions, we take time to recognize our achievements and celebrate our diversity.  We are dedicated to creating a culture of inclusion and collaboration and are committed to continuous learning by offering ongoing skill building and training for our staff.  Fueled by our aspiration to deliver accelerated growth for our company and to make people’s lives better, there’s never been a more exciting time to join the team and shape the future of AstraZeneca Operations

As a QC Information Systems (QCIS) Senior Specialist, you will act as an administrator of various GMP computerized systems and serve as a business analyst between lab groups and IT. You will be involved in Enterprise projects such as Empower, Biovia Laboratory Execution Systems (LES), Labware LIMS, and other digital initiatives. Candidates should possess a technical understanding of Information and Enterprise systems. You will be responsible for day-to-day job functions, administration, validation, and data integrity tasks, and can independently represent the team for site and global initiatives.

Accountabilities

- Perform day-to-day activities and application administration of lab and manufacturing quality control computerized systems, including maintaining static data.
- Support QC lab functions by providing solutions to a variety of technical problems.
- Participate in software/computer system validation, IT for software/computer applications, and fulfill all networking and security requirements for enterprise software applications.
- Facilitate and coordinate training of new and existing local admins, preparing training materials as necessary.
- Execute protocols, reports, investigations, change management, document authoring, etc., using Veeva on behalf of the department.
- Support QC information system lifecycle management activities from concept, development, validation, implementation, maintenance, to retirement.
- Provide audit support to the labs with a strong understanding of administration and data integrity of validated GMP systems.
- Self-manage tasks and assignments effectively, as well as lead small projects within the team, collaborating with peers, global counterparts, and leadership.

Essential Skills/Experience

- Bachelor’s Degree in a science-related field.
- 5+ years in systems or lab setting.

Desirable Skills/Experience

- Degree in Information Systems/Technology or Biotechnology related field.
- Experience in information management and/or a scientific lab setting.

At AstraZeneca, our work in Quality is both important and valued. We are at the forefront of innovation, constantly trialling the latest models and technologies to improve reliability and excellence in our processes. Our team is proactive, science-based, and solutions-oriented, always striving to deliver what will have the biggest impact on our patients. We foster an inclusive and friendly community where each voice matters, empowering us to work effectively in a high-risk environment. With a clear focus on growth and innovation, there are always exciting opportunities to quality assure new products as we go to market around the world.

Join us at AstraZeneca and make a real difference in patients' lives!

The annual base pay (or hourly rate of compensation) for this position ranges from $100,786.00 to $151,180.00 Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors

Date Posted

01-Apr-2025

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.