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Quality Assurance Specialist II
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$99,790 - $129,140
Full-time
- Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
- Review executed production batch records, environmental monitoring data (as required), and associated documentation, including any deviation and investigation reports related to lot release of Commercial/Clinical Drug Product in support of product disposition.
- Lead or coordinate investigations and corrective and preventive action (CAPA) recommendations
- Interact with key stakeholders such as Formulation and Process Development, Manufacturing, Engineering, Packaging, and Regulatory Affairs to ensure that Commercial / Clinical Drug Products are manufactured in accordance with established procedures, cGMPs, and to appropriate regulations.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
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