Location:Frederick, United StatesJob reference:
Sep. 23, 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 III 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
You will be responsible for assuring the quality of licensed or clinical products manufactured at MedImmune or at contract manufacturing sites. You will support and provides advice to a number of functional areas including Manufacturing, Facilities & Engineering, Quality Control, and other departments. Interpret and implement quality procedures, manage quality systems and assist in maintaining site regulatory compliance documents. 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. You will have thorough working knowledge of FDA, EU and other global GMP guidance and regulations. Ensure site compliance to the Quality Systems is maintained for operations at the Frederick site. Design, improve and implement Quality Systems at the Frederick, MD site(s). Identify and support the electronic quality management system, TrackWise, to ensure the timely review of records, accuracy of information, availability of data/information, generation of reports. Create new and improve existing procedures and systems to support the documentation and resolution of Deviation investigations, Change Controls, CAPAs. Lead the compilation and publication of quality metrics and analysis according to defined Corporate and Site objectives as established in the Quality / Business Objectives for Manufacturing and QA activities on a daily, monthly / quarterly basis (Quality Council, reporting to Corporate activities). Support the responsibility of the Quality Systems team for generation of Product Quality Review/Annual Product Review documents. Support and participates in US and EU Regulatory Inspections. Support the Risk Management Program Ensures compliance to cGMPs and identifies potential compliance risks. Contribute to the completion of specific programs and projects. Ensure Corrective Actions implemented in response to observations are tracked to closure within target due dates, and escalated to management as required. Provide Quality Systems Training including GMP, GDP, and Deviation Management for Manufacturing, Quality Control, Facilities, Materials Management and Quality Assurance Personnel. Review, assess and approve non conformances and change controls and corrective actions. Participate and lead interdisciplinary projects, as required. You will use an electronic system with tools such as TrackWise and SAP. Ability to learn the use of Operational Excellence tools such as DMAIC and root cause analysis. Ability to communicate and work effectively with internal customers. Ability to review and understand analytical data. Ability to understand and implement priorities and work load and to establish strong collaborative relationships with peers. Lead, oversees complex projects and programs, interdepartmental and corporate goals. Externally recognized and consulted strategist. Provides training to new employees. Assist in the supervision of activities of other QA Specialists. Develop and design change initiatives; evaluate corporate business processes and proposes improvements. Lead strategic planning where impact is interdepartmental or corporate. Effectively drives solutions and improvements for complex, critical cross-functional and corporate projects.
* Bachelor's Degree with seven or more years of biotech/pharmaceutical industry experience with more than three years of experience in QA.
* Master's Degree with three or more years' experience in biotech/pharmaceutical industry with two or more years of experience in QA.
* Experience working in a highly regulated environment.
* Good understanding of basic scientific principles. Understanding of biotech manufacturing processes.
* Good understanding of cGMPs, Regulatory standards and concepts. General knowledge of other related disciplines.
* Provides technical solutions to a wide range of complex problems. Solutions are imaginative, thorough, practicable, and consistent with organizational objectives.
* Works independently with only minimal direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
* Frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects. Provides direction and guidance to other team members.
* Degree in (FDA, EMA)Science (e.g. Biology, Chemistry) or Engineering (e.g. Mechanical)
* Excellent written and oral communication skills.
* Proficiency with Word, Excel and Power Point.
* Prior experience with Lean Six Sigma.
* Excellent collaboration skills, with focus on customer service
* Experience leading and working effectively with cross-functional teams with representatives from various sites, departments and levels.
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.