Specialist III, QA Operations (Contract)

What You'll Do:

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.  

About You:

- 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.  

- Strong understanding of cGMP, ICH guidelines, and applicable regulatory requirements.  

- Proficient in reviewing manufacturing batch records, analytical data, and quality documentation.  

- Excellent attention to detail and ability to make sound quality decisions.  

- Strong organizational, problem-solving, and communication skills.  

- Ability to work independently and in a cross-functional team environment.  

- Proficiency with electronic quality management systems (e.g., MasterControl) is an asset.