The Technician I, QA - Operations provides direct support for all manufacturing activities. This position supports the Quality Systems within the Quality Assurance Unit ensuring compliance with federal regulations for current Good Manufacturing Practice (cGMP) for finished pharmaceuticals. Provides Quality Assurance support for all manufacturing activities occurring in classified cleanroom areas. This opening is a night shift opening - 6p-6a.

Job Responsibilities:

• Review batch records during active manufacturing 
• Perform routine manufacturing area line clearances
• Maintain gowning qualification for access to aseptic manufacturing areas 
• Perform Quality Assurance compliance review of Manufacturing and Quality logbooks and records
• Assist in routine filing of Quality records
• Perform internal compliance audits
• Participate in Investigations for Deviation Reports
• Participate in writing and revising Standard Operating Procedures, Deviations and CAPAs when applicable under direct supervision 
• Perform other duties as assigned

Required Skills: 

• Excellent interpersonal skills and the ability to communicate well orally and in writing
• Ability to multi-task and handle multiple priorities in a dynamic environment with changing priorities
• Attend to details

Education and Experience Requirements:

• Bachelor’s degree in a science or related field is strongly desired, or High School diploma with 3 years relevant GMP or regulated industry experience
• Experience supporting manufacturing is preferred
• Experience with computers, including Microsoft Office, Windows

EOE, including disability/vets.