QA Specialist II
Location:
Gaithersburg , Maryland
Posted:
November 23, 2017
Reference:
R-016835
If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  As a QA Specialist II in Gaithersburg MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Responsibilities:
Responsible for assuring the quality of clinical products manufactured at MedImmune and contractors. 
The Specialist supports a number of functional areas including manufacturing, facilities and other Quality departments. Implements quality policies, manages quality systems and assists in facilitating regulatory compliance inspections.Utilizes Operational Excellence tools such as FMEA, DMAIC and root cause analysis.   Quality at the source utilizing on the floor real time review and investigations. Review documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval. Responsible for assuring the quality of clinical products manufactured at MedImmune and contractors.  The Specialist supports a number of functional areas including manufacturing, facilities and other Quality departments.  Implements quality policies, manages quality systems and assists in facilitating regulatory compliance inspections. Utilizes Operational Excellence tools such as FMEA, DMAIC and root cause analysis.   Quality at the source utilizing on the floor real time review and investigations.  Review documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval. 
Requirements:
Education: B.S. in Biology, Chemistry, Engineering or related fields. 
Experience:  3+ years' related experience in a GMP environment
Next Steps - Apply today!
To be considered for this exciting 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 a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca

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