Qa Operations Specialist (3Rd Shift)
By Novartis At , Indianapolis $88,000 - $132,000 a year
Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
Assist functional areas with achieving timely and compliant final product disposition of the product.
Review, approve and support procedures and production/testing records as required and assist in the training of site associates.
Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.
Support FDA/Regulatory interactions for the site activities and products to ensure successful regulatory submissions and inspections.
Other related duties as assigned.