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Quality Assurance Specialist Ii

3 months ago

Frederick, United States AstraZeneca Full time

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 teamwork 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 II within the Quality Systems group at Frederick Manufacturing Center. This role is designed to assist in all areas of quality systems, guided by the quality leads on the team. If you're ready to pioneer a new 'Quality way', this is the opportunity for you

**Shift: 2nd Tuesday through Friday 2pm-12 4 days a week**

**Accountabilities**:
As a Quality Assurance Specialist II, you will perform selected quality assurance activities, including reading, understanding, and following SOP’s and complying with cGMP’s. You will write new standard operating procedures or revise existing documentation utilizing document management systems. You will also support the issuance and reconciliation of GMP documentation and use electronic system tools such as Trackwise, EQV, FileTrail, Power BI and SAP.

You will review documented information from your functional area, report abnormalities, assist in the implementation of new processes, and provide task-oriented training to Specialists. You will also initiate and/or review and approve minor deviations; complete tasks related to CAPA and Change Control action items.

**Essential Skills/Experience**:

- Minimum Bachelor's degree; biology, engineering or science-related field preferred.
- 2-4 years industry experience

**Desirable Skills/Experience**:

- 2 years experience in QA preferred

At AstraZeneca, our work in Quality is important and valued. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We are a team of ambitious people, who want to go far and we're all here to achieve. We take Quality seriously and there's a clear ambition to shift the mindset around Quality. It's more than just following procedures and regulations; it's about adding value for our patients, which ultimately benefits the business.