Qa Jobs 2026 (Now Hiring) – Smart Auto Apply

Lot Disposition Oversight:

- Review, evaluate, and approve all batch records, analytical testing data, and supporting quality documentation prior to lot release. 

- Ensure all manufacturing and testing activities are performed in compliance with cGMP and applicable regulatory requirements. 

- Oversee lot disposition processes for materials produced internally and by CMOs. 

Data Review and Approval:

- Review and assess data generated by CMOs, including in-process and release testing results.

- Evaluate data generated by CTLs and in-house testing to verify compliance with specifications and regulatory expectations. 

- Confirm resolution of deviations, investigations, and change controls prior to lot disposition. 

- Review stability data, including test records, interim reports, and final stability reports, for accuracy, completeness and compliance 

Compliance and Continuous Improvement:

- Ensure timely completion of lot disposition activities to meet clinical and commercial supply timelines. 

- Identify process gaps and drive continuous improvement initiatives in quality systems related to lot disposition. 

- Support internal and external audits related to lot disposition processes. 

Cross-Functional Collaboration:

- Partner with Manufacturing, QC, Supply Chain, and Regulatory Affairs and Process and Assay Development as required to address quality issues impacting lot disposition. 

- Provide guidance to internal and external stakeholders on quality standards and regulatory compliance. 

- Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy) or equivalent experience. 

- Minimum 5 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or related regulated industry, including experience with lot disposition. 

- Experience working with CMOs and CTLs in a cGMP environment preferred.