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 IV - Supplier Quality/Incoming Raw Materials in Boulder, CO , 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 IV - Supplier Quality/Incoming Raw Materials will start in January 2017.
You will be responsible for Quality Assurance activities that directly support execution of quality management of suppliers and incoming raw materials used for biologics manufacturing at the Boulder Manufacturing Site. Your responsibilities include evaluation and disposition of labeling, raw materials, intermediates and finished products through timely compliance evaluation of batch records, laboratory results and other cGMP documents. You will support internal audits of manufacturing, analytical testing, labeling areas to ensure compliance with SOP and regulatory requirements per the requirements of the self-inspection program.
You will have quality system oversight and/or performance of audits, change control, product quality complaint and deviation investigations, issue management and escalation, raw material release, quality agreements between external suppliers and the Boulder Biologics Manufacturing Site. You'll be responsible for the preparation and submission of Supplier Quality Assessments. You'll have regulatory agency interactions. You will represent Quality Assurance on new product Introductions, new supplier introductions and transfer projects related to Supplier Qualification and raw materials. Facilitate interactions with senior management and internal stakeholders. Create trend and metric reports as required for delivery to peer and management groups. Assist with supplier audits. Manage workflows to assure timely supply of product. Maintain a high level of understanding of relevant production processes and quality systems. Perform Quality Assurance technical review of current Good Manufacturing Practice documentation. Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality system. Accountable for providing Quality Assurance Technical support for Process Execution related to cost saving initiatives, value creation, performance standards, continuous improvements, and issue resolutions. Collaborate with, and influence, other team members to facilitate process improvements and risk assessments. You will benchmark internal and external Quality Assurance practices to identify innovative efficient and effective practices.
•Bachelor's Degree in a science/technical field such as Pharmacy, Biology, Chemistry
•Minimum ten years prior pharmaceutical or biopharma experience including at least five years of experience in quality assurance roles
•Experience working cross functionally across the supply chain with groups such as regulatory, global supplier quality, manufacturing, procurement and account management
•Excellent verbal and written communication skills
•Able to create presentations and report to senior management and industry audiences
•Possess strong leadership and project management skills.
•Able to translate and apply global regulatory requirement and cGMP
•Prior experience in Good Manufacturing Practice and compliance management environment
•Flexibility to be based in Boulder or Longmont, CO Desirable Requirements
•Experience with TrackWise, LIMS and SAP or related systems
•External supplier management experience
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