We are currently seeking a QA Batch Release Associate III who is responsible for assuring compliance with Quality Assurance (QA) requirements, applicable regulatory requirements, including assisting with audits, training programs, and documentation review. The Associate III collaborates with internal team members to ensure compliance to specifications, processes, and procedures.

Responsibilities:

• Reviews and approves executed and non-executed lot file documentation in support of the manufacture and testing of Drug Substance and Drug Product. 
• Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis.  
• Performs reviews of production batch records and associated data for product release, and determines if records are within range of cGMP regulations.
• Provides QA oversight and performs real time, on-the-floor documentation review during manufacturing operations.
• Represents QA on assigned clients and attends client meetings.
• Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.