What are the responsibilities and job description for the Senior QA Associate - Biopharmaceuticals position at ApTask?
About the Role:
The Senior Associate Quality Assurance position plays a critical role in ensuring the quality of our biopharmaceutical products. As a member of our Plant QA organization, you will be responsible for providing daily oversight of the Drug Product manufacturing areas. This includes reviewing electronic batch records, approving SOP revisions, managing the Maximo System, and providing quality support and CAPA records management.
Key Responsibilities:
The Senior Associate Quality Assurance position plays a critical role in ensuring the quality of our biopharmaceutical products. As a member of our Plant QA organization, you will be responsible for providing daily oversight of the Drug Product manufacturing areas. This includes reviewing electronic batch records, approving SOP revisions, managing the Maximo System, and providing quality support and CAPA records management.
Key Responsibilities:
- Purposeful presence on the manufacturing floor, including inspection support, ASP and QA assessments
- Electronic batch record review
- SOP revision approval
- Maximo System management
- Quality support and CAPA records management
- MES revisions and approvals
