we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a QA Specialist III/IV, Disposition
in Frederick, MD
, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.Operations
at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.Main Duties and Responsibilities
You will utilize quality assurance system in compliance with current good manufacturing practice regulations. You will support the evaluation and disposition of finished products through timely compliance evaluation of batch records, laboratory results and other cGMP documents. You will support identification of root causes, recommends and implements corrective actions to prevent recurrence. You will employ metrics to track the performance of the teams' processes. You will provide leadership and guidance to peers in the QA department and functional areas. You may assist in the training activities of other QA personnel.Essential Requirements
Education and Experience
- Bachelors degree required
- 7-10 years of experience in biopharmaceutical/pharmaceutical industry.
- You will utilize quality assurance systems in compliance with current good manufacturing practice regulations and corporate policies and procedures.
- You will be responsible for assembling and reviewing the necessary documentation for lot disposition.
- You will interface with other functional areas to ensure all deliverables are obtained for lot disposition.
- You will be responsible for overseeing incoming/outgoing shipments of finished product and master/working cell banks, including clinical material as well as freeze/thaw.
- You will review data and issues CoA for Drug Product.
- You will support product launch.
- You will provide leadership and guidance to peers in the QA department and functional areas.
- You will assist in the training activities of other QA and Site personnel.
- You will create trend and metric reports as required for delivery to peer and management groups.
- You will utilize Lean Methodology to implement Continuous Improvement.
- You will use of the following systems is required: SAP, GQCLIMS, Informatica, TrackWise, AZDoc
You will possess excellent writing, verbal and listening skills. You will have frequent communication with other department representatives such as QC, SCO, Validation, External Quality.
You will disposition finished product in compliance with applicable procedures and cGMPs.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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.