Quality Assurance Specialist / Pharma

Reporting to the Quality Assurance Mananer , Quality Assurance Specialist will be responsible for maintaining quality assurance systems including investigations, deviations, and corrective and preventative actions. This individual will also be responsible for batch record review and approval, disposition of drug product, facilitate vendor management processes, and review documents needed to maintain GMP compliance.Responsibilities:

• Support and maintain the PMI Solutions Quality Management System (QMS)
• Work with Analytical Development and other GMP functional areas to close out deviations, investigations, and CAPAs in a timely manner
• Review executed documents including batch records, engineering reports, and validation reports for regulatory compliance and adherence to PMI’s procedures
• Represent Quality Assurance during audits and perform internal and external auditing
• Provide support to product development and analytical development to ensure compliance with cGMPs and applicable regulatory requirements
• Facilitate vendor management processes