Our Client, a global, science-led biopharmaceutical business is seeking a QA Specialist to join their growing team. This is a great opportunity to work at a household name, get industry best training, and work with state of the art equipment, systems and products.
Utilizes quality assurance system in compliance with current good manufacturing practice regulations.
Administers the change and Deviation and corrective action systems for assigned products and quality systems.
Maintains database; generates standard and ad hoc reports.
Manages work flows to assure timely supply of commercial product.
Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely compliance evaluation of batch records, laboratory results and other cGMP documents.
Investigates and assesses the impact of minor and major deviations that may occur during manufacture, testing or distribution of products or during the administration of quality systems.
Identifies root causes and recommends and implements corrective actions to prevent recurrences.
Performs trend analysis to monitor process and facility performance.
Employs metrics to track the performance of operations and quality systems.
Reviews validation protocols and summary reports.
Supports other groups on completion of annual review and annual product reports.
Performs in-plant inspections of active production areas to resolve problems early and to ensure compliance with SOP and regulatory requirements.
Some 2nd shift work may be required as per departmental need to support the manufacturing schedule.
732-661-0400
info@astrixinc.com