Qa Specialist I
Current● Review and conduct investigations for deviations in production and testing (variances, material non-conformance reports, out-of-specification/out-of-trend investigations, quality control reports).● Ensure process validation and qualification requirements are established in approved protocols and results of the validation and qualifications are adequately presented in approved reports.● Provide guidance within the approved systems and procedures as it relates to GMP production and release of products. ● Manage change controls in support of production and release activities.● Develop and report appropriate metrics for review by management and customers.● Coordinate the release of products to customers within the approved systems and procedures.● Present the status of Quality Assurance related items to customers and Integrated Product Teams, including batch release and investigation status.