QA Specialist - Quality Systems & Risk
Be the voice of the patient!
Be proud to play a meaningful role as the eyes and ears of our patients. Unafraid of the responsibility, we look after and sign off each batch as if the medicine were for our own family. All our contributions add up to improving the quality of patients’ healthcare and ultimate their quality of life.
Support Quality, Compliance, and Manufacturing of Live Attenuated Influenza Vaccine (LAIV) via ownership and continuous improvement of business processes. Lead these processes by applying the AZ Business Process Management (BPM) framework to set priorities, balance resource workload, support/enable decision-making, and build impactful process networks.
Apply Lean principles such as problem-solving, 5S, and visual management. Guide cross-functional team(s) to ensure execution of owned business processes, such as Deviation Investigations, CAPA planning, Change Control and Change Oversight, Product Quality Complaints, Supplier Initiated Changes, and Validation review and approval.
Becomes actively involved in daily operations when required to meet schedules or to resolve complex problems. Provides direction to staff concerning US and international regulations and compliance issues. Provides subject matter expertise during the planning and execution of internal & external regulatory inspections (FDA, EMA, MHRA, etc). Works directly with the Validation department to provide QA support for the development, execution, and review of validation life cycle documents.
Maintain procedures, quality records and provide direct QA support to detail and resolve deviations, environmental monitoring excursions, product complaints, supplier changes, manufacturing investigations, and risk assessments.
Supports the Product Quality Complaint process, including (but not limited to) management of complaint investigations, performing periodic complaint trending, and reporting of key process metrics.
Support and provide key participation in local self-inspections, internal audits, and Regulatory Inspections. Act as Local Process Champion (LPC) on regional business process networks by providing SME knowledge to the network and driving continued improvement of global business processes
- Associates in Biology, Chemistry, Engineering, or related field.
- 3 years confirmed work in the Biopharmaceutical/pharmaceutical industry.
- 5 years exhibited expertise in Quality Assurance, Quality Control, or Validation.
- Understanding of root cause analysis and investigation techniques/methodologies.
- Experience supporting regulatory inspections.
- Knowledge of LEAN manufacturing
- Knowledge of Human Organization Performance.
- Experience working in an Aseptic manufacturing environment.
- Experience with data analytics applications.
Closing Date15-Feb-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.