AstraZeneca Pharmaceuticals LP QC Lead in Coppell, Texas
At AstraZeneca, 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 Quality Control Lead, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. North American Commercial is the 'face' of AstraZeneca and MedImmune to our many healthcare clients. They represent many of the most well recognized and respected products in the industry, and build strong relationships with healthcare professionals.
Provide expert technical and analytical leadership, advice and direction to the Quality Control function including instrumentation and methodology troubleshooting, non-routine analysis, and the evaluation and exploitation of new technology. The individual should be qualified to graduate level or equivalent in a scientific discipline, with extensive experience of working in a Good Manufacturing Practice laboratory environment. Will have strong knowledge and understanding of analytical chemistry and laboratory instrumentation, as well as Good Manufacturing Practice/Good Laboratory Practice. Must have a comprehensive understanding of the Quality Control function and its role and importance to the wider business.
Additionally, must be proficient in Lean 6 Sigma and the application of Lean in the laboratory environment.Responsible and accountable for the throughput in the QC laboratories to support business demands.
· Deliver QC operational performance. Ensure QC capacity and capability is in place to meet demand.
· Work as part of the Americas and Global QC network to standardize ways of working, share best practice and integrate into the AstraZeneca supply network
· Provides analytical expert knowledge and support to the Quality Control Function for the most complex troubleshooting issues, novel situations and oversees the delivery of training and coaching. Optimizes performance outcomes of direct reports and ensures individuals understand the contribution they make.
· Oversees the analytical technology transfer of Quality Control methodology into and out of Operations
· Leads and directs the introduction of new technology a systems into the Quality Control Function, oversees and manages initiative to ensure that the Quality Control function remains contemporary and competitive
· Follows AZ’s financial policies, manages people resources to policy requirements and delivers the QC budget.
· Monitors and maintains compliance in accordance with cGMP, SHE ,SOX and business procedures. Is accountable for ensuring compliance is understood and maintained across the QC labs. Uses expert knowledge to support regulatory inspections where required
· Accountable for the delivery of a Lean and Agile work culture in the lab environment emphasizing standard ways of working and continuous improvement.
Bachelor’s degree in a science or engineering curriculum.
A minimum of ten years of experience as a Quality professional in the pharmaceutical manufacturing industry (finished drug product or Active Pharmaceutical Ingredients / complex chemical processing of excipients), in progressively more responsible management and leadership positions.
Demonstrated Lean experience and understanding.
Advanced knowledge of cGMP requirements, quality systems, applicable to the QC Operations
Demonstrated management skills; ability to influence and engage direct and indirect reports and peers.
Strong written, oral, interpersonal, and presentation skills and the ability to effectively interface with all levels of management and staff.
Must be willing to address emergent factory quality and compliance issues by being available via telephone during off hours.
Graduate degree in engineering, science, or business is desirable.
Application of Lean ways of working in the QC environment.
Next Steps -- Apply today!
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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.