QA Manufacturing Specialist

The QA Manufacturing specialist works side by side with the Manufacturing Operations team to ensure products meet GBI’s standards and applicable regulatory requirements throughout the entire manufacturing process. The candidate implements and performs appropriate quality measures that ensure the compliance of the manufacturing floor.

• Provide Quality Assurance support for the operations floor ensuring manufacturing meets GBI standards and regulatory requirements.
• Regularly monitor the compliance of the manufacturing floor by conducting routine walkthroughs.
• Ensure quality issues are fully investigated and appropriate corrective actions are implemented.
• Create, revise and review standard operating procedures, master batch records and material/product specifications.
• Supports and oversees batch manufacturing operations and media fill qualifications.
• Performs the review and release of the cleanrooms and equipment for manufacturing operations.
• Performs review of in-process buffer and final formulation buffer manufacturing process and records.
• Performs review of the Pest Control Program at the site.
• Performs periodic review of equipment and room logbooks on the manufacturing floor.
• Provides QA support for the electronic environmental system and the NetSuite enterprise system.
• Performs review and approval of executed batch records in a timely manner.
• Coordinates the archiving of executed records from the manufacturing floor with QA Documentation Control.
• Prepares the batch Certificate of Compliance and Certificate of Assurance, as applicable.
• Review and approval of executed cleaning forms and autoclave records.

Education and Experience Required

• Knowledge of quality assurance terminology, methods and tools.
• Minimum of 5 years’ experience working in a pharmaceutical manufacturing environment
• Experience in biotechnology and aseptic technique manufacturing.
• Minimum of 1 year experience working in cleanroom environments.
• Deep knowledge of cGMP and Data Integrity requirements.
• High school diploma minimum education.
• Demonstrate excellent written and verbal communication skills.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.