Location:Frederick, United StatesJob reference:
Sep. 16, 2016
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 Frederick, 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.
Main Duties and Responsibilities
The QA Specialist will collaborate with the multi-disciplined peers to assure Quality standards are met in the production process, and utilize quality systems in compliance with current good manufacturing practices to promote a quality culture.
This role will be called upon to:
* Administer the change control and Deviation and corrective action systems for assigned products and quality systems.
* Maintains database; generates standard and ad hoc reports.
* Manages workflows to assure timely supply of product.
* Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely compliance evaluation of batch records, laboratory results and other cGMP documents.
* Supports internal audits of manufacturing, analytical testing, labeling areas to ensure compliance with SOP and regulatory requirements per the requirements of the self-inspection program.
* Document systems
* Change management
* Product manufacturing oversight
* Electronic system usage with tools such as Trackwise and SAP
* Product and raw material disposition
* Administration of the document management system
BS in pharmacy, science, engineering, or related field required.
4 to 7 years of experience in Quality Assurance required
2 to 4 years of experience in manufacturing a plus
2 to 4 years of experience in validation a plus
Experience with a start-up or new facility a plus
Ability to learn the use of Operational Excellence tools such as DMAIC and root cause analysis.
Ability to process map work flow and write Standard Operating Procedures (SOPs).
Ability to communicate and work effectively with internal customers as well as third party laboratories and manufacturing sites.
Demonstrated technical ability and skills in assigned work area to include product, process and/or testing knowledge.
Ability to review and understand analytical data.
Ability to understand and implement priorities and work load and to establish strong collaborative relationships with peers.
Must be able to work in a cross functional team
Must be able to accommodate the schedule and demands of a production environment.
Must be available to work shift hours: days, evenings or weekends. May be assigned to a day, evening or weekend schedule at the discretion of business needs.