Head of Software Quality Assurance jobs in Maryland

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. 

Join us at AstraZeneca as a Quality Assurance Specialist III/IV within the Quality Systems group at Frederick Manufacturing Center. This role is an exciting opportunity to pioneer a new 'Quality way' and develop your expertise in a supportive and challenging environment. You will primarily assist with project management activities for product quality reviews (PQRs) and provide support for various quality system value streams. If you have a background in data analytics, you will be a valuable asset in our ongoing digital journey.

Accountabilities:
As a Quality Assurance Specialist, you will perform selected quality assurance activities, including reading and understanding SOP’s, complying with cGMPs, writing new standard operating procedures, and supporting the issuance and reconciliation of GMP documentation. You will also review documented information from your functional area, assist in the implementation of new processes, and provide task-oriented training to Specialists. Additional responsibilities for QA Specialist IV include serving as a subject matter expert for area core functions, providing support for both internal and external inspections, and leading periodic review of existing QA processes.

Essential Skills/Experience:
- QA Specialist III: Minimum Bachelor's degree; biology, engineering or science-related field preferred. 3-5 years industry experience.

- QA Specialist IV: Minimum Bachelor's degree; biology, engineering or science-related field preferred. 7 years industry experience.

Desirable Skills/Experience:
- QA Specialist III: 4 years experience in QA preferred.

- QA Specialist IV: 4 years experience in QA preferred. Excellent written and communication skills. Strong data analytic focus with solid experience in quality systems.

At AstraZeneca, we take Quality seriously. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We are proactive, science-based, and solutions-oriented. Our ambition to go far keeps pushing us forward, but it's our pragmatic focus that keeps us delivering what will have the biggest impact on our patients. We are a team of ambitious people who want to go far and we're all here to achieve. We work cross-functionally, across sites and regionally, sharing expertise and offering support to others. It's an inclusive and friendly community here where each voice matters.

Are you ready to make a difference? Apply today to join our team in Operations as a Quality Assurance Specialist III/IV – Quality Systems!

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.