Quality Assurance Specialist
- Type: VMS
- Job #38622
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.