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 Supervisor 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 ensuring the quality of products manufactured at the facility. Implement scalable solutions, including quality policies, manages quality systems, and facilitates regulatory inspections. Provide leadership and strategy development guidance in areas of regulatory compliance, quality practices and procedures and quality systems to other functional areas. Provide leadership to a staff of Quality Specialists who will report into this position. You will be responsible for the quality oversight of manufacturing operations utilizing efficient batch record review processes and investigations. Document systems, investigation systems and/or change management utilizing a risk based approach. Oversee and manage the Track Wise system for deviations, CAPA, change control, OOS, etc. Ensure that root cause investigations are performed, recommend and/or support implementation of corrective actions to prevent recurrence. Review and approve commissioning, qualification and validation documents (DQ, IQ, OQ, PQ, Steam and Cleaning Validation). Author Standard Operating Procedures, Non-conformances and change controls as required. Work with a cross-functional team of manufacturing, QC, Engineering and Technical Services. Review of documentation associated with incoming receipt and disposition of raw materials used for clinical and commercial manufacturing. Product release utilizing systematic process flows for internal or external customers. Line management and staff supervision includes scheduling, recruiting and performance management. Solid operating skills including timely decisions, managing and measuring work along with good overall timeline and project management skills. You must have the ability to develop staff and set mid and short term priorities. Perform trend analysis to monitor process, systems and facility performance. Create and employ metrics to track the performance of operations and quality systems. Support audits of manufacturing, analytical testing, contractor/supplier and labeling areas to ensure compliance with SOP and regulatory requirements per the requirements of the self-inspection program. Identify areas of potential risk and assists the FMC management team in developing and implementing plans to address them. Alert management to associated liability issues. Provide QA support to QC group by reviewing and approving QC documents (analytical testing, qualification, method validation etc.).
* Bachelors of Science/Engineering or related fields.
* Five or more years of work experience in biopharmaceutical/pharmaceutical industry. Seven or more years of experience in biopharmaceutical/pharmaceutical industry. Three or more years of supervisory experience.
* Seven or more years of experience in biopharmaceutical/pharmaceutical industry.
* Four or more years of experience in QA, manufacturing and validation experience.
* Ability to implement strategic initiatives and translate into tactical solutions; participates in planning strategic initiatives.
* Frequent use and application of technical standards, principles, theories, concepts, and techniques.
* Familiar with the use of OE tools/lean manufacturing.
* Knowledge of both US and international regulatory guidelines and standards for biologics.
* Ability to independently identify and resolve relatively complex problems through good planning and decision making utilizing functional and technical skills.
* Ability to manage conflict and stand alone on certain issues.
* Ability to mentor, develop and provide constructive feedback to staff.
* Ability to work in a cooperative team environment with cross-functional groups.
* Must be available to work 12 hour shift, may be assigned to a day or night work schedule.
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.