Quality Assurance Associate
Harba Solutions Inc. - indianapolis, IN
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Responsibilities:Review and approve batch records, validation documents, and other quality-related documentation to ensure they meet industry standards and regulatory requirements.Assist in the development and implementation of quality control procedures.Perform routine inspections and checks to ensure compliance with established quality standards.Participate in internal and external audits and inspections.Prepare audit reports, track corrective actions, and ensure timely resolution of non-conformances.Monitor and enforce compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines.Support the training and development of staff on quality assurance processes, procedures, and best practices.Collaborate with cross-functional teams to implement corrective and preventive actions.Contribute to continuous improvement efforts by identifying areas for process enhancements and operational efficiencies.Qualifications:Bachelor's degree in Life Sciences, Chemistry, Pharmacy, or a related field.5+ years of experience in quality assurance or a related field within a CDMO or pharmaceutical environment. Experience with GMP and regulatory requirements is highly desirable.
Created: 2024-10-07