What are the responsibilities and job description for the Quality Assurance / Quality Control Specialist position at Turbare Manufacturing LLC?
Quality Assurance / Quality Control Specialist
- Overview: Turbare Manufacturing, a reputable 503B sterile compounding facility, seeks a meticulous and detail-oriented Quality Assurance/Quality Control Specialist to uphold stringent quality standards in our sterile compounding operations. The ideal candidate will ensure compliance with regulatory guidelines, maintain product integrity, and contribute to enhancing our manufacturing processes.
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Description: The essential functions include, but are not limited to, the following:
- Establish and uphold quality control systems to ensure adherence to regulatory standards (FDA, cGMP, USP) in sterile compounding activities.
- Conduct thorough inspections and audits of sterile compounding processes, equipment, and facilities to detect deviations, non-conformities, and areas for enhancement.
- Develop and manage documentation such as Standard Operating Procedures (SOPs), batch records, and quality assurance protocols tailored to sterile compounding operations.
- Perform rigorous testing of sterile compounded products, encompassing raw materials, in-process stages, and finished products, utilizing appropriate analytical techniques and equipment.
- Investigate and resolve quality deviations, anomalies, and customer complaints promptly, implementing corrective and preventive actions as deemed necessary.
- Collaborate closely with cross-functional teams to implement quality enhancements, validate processes, and introduce new sterile compounded products.
- Facilitate regulatory inspections and audits by providing comprehensive documentation and support throughout the process.
- Deliver training and guidance to sterile compounding personnel on quality standards, procedures, and optimal practices.
- Stay abreast of industry developments, regulatory updates, and best practices in sterile compounding quality assurance and control.
- Maintain meticulous and up-to-date records of quality-related activities, encompassing documentation of inspections, tests, and corrective actions.