What are the responsibilities and job description for the Senior Quality Assurance Manager position at Takeda Pharmaceutical?
At Takeda Pharmaceutical, we understand the importance of quality in our products and services. As a QA Specialist II, you will be responsible for reviewing and approving raw materials following SOPs, releasing materials for manufacturing use, resolving issues related to materials release, and overseeing preprinted material accountability, material receipt, and JDE inventory management system issues.
Key Accountabilities:
- Manage Final Container sampling processes and Quarantine and Reject processes for materials and finished products
- Be a subject matter expert (SME) during internal and external regulatory audits, presenting Quality operations to auditors
- Ensure compliance with cGMP guidelines and identify opportunities for process improvements
As a QA Specialist II, you will also be responsible for collaborating with cross-functional teams to drive quality initiatives and improve overall product quality.
Requirements:
- Bachelor's degree in science, engineering, or other related technical field
- ~6 years of related work experience
- Experience with visual inspection and AQL processes related to parenteral drugs