Specialist, Quality Assurance for QC

Specialist, Quality Assurance for QC

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Purpose and Scope :

The Specialist, Quality Assurance for QC will be responsible for providing direct Quality oversight and support for Quality Control and US Methods and Tech Transfer laboratory operations and method qualification activities. This role will ensure adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This role will collaborate with cross-functional teams such as other Quality Assurance, Validation, Manufacturing, and MSAT teams to ensure quality and compliance.

Essential Job Responsibilities :

Quality Oversight of Laboratory Operations :

• Provide QA oversight of QC laboratory activities, including testing of raw materials, in-process samples, drug substance and drug product, and environmental monitoring.
• Conduct routine area walkthroughs to ensure laboratories operate in a state of control and comply with current Good Manufacturing Practices (cGxP).

Test Method and Material Lifecycle Management :

Technical Leadership and Support :

Data and Documentation Review :

Quality Systems and Compliance :