Quality Assurance Specialist

Responsibilities:

• Assists in the process of creating batch records and forms needed to support the process.
  • Batch Review
• Completes initial review of batch records in real time and provides feedback on manufacturing operations.
• Coordinates with QC -Equipment and QC – EM Roles on manufacturing needs.
  • Initiates and investigates Occurrences that occur during manufacturing.
  • Responsible for tracking manufacturing errors and providing feedback for metrics.
  • Technical Writer and resource for policies, Standard Operating Procedures, forms, worksheets, and job aids in support of quality and manufacturing operations.
• Assists and supports manufacturing in identifying needed policies, Standard Operating Procedures, and other required documents.
  • Ensures manufacturing employees are current on required training for them to complete operations.
  • Looks to implement and reinforce best practices used in manufacturing operations in conjunction with production staff.
  • Helps to be liaison for manufacturing to support projects.
  • Maintain annual competencies in required quality functions and remain up to date in required EHS LMS modules.
  • Assist in training other QA/QC members in ACT Quality Systems.
  • Assist in the maintenance of quality electronic systems.
• Participate in 10 hours of continuing education annually in cellular therapy or quality topics.
• Experience with MasterControl beneficial

Top skills you need to have:

• GMP Knowledge
• Master Control Knowledge nice to have
• Tissue Culture & Cell Culture