QA Manager

As a Quality Assurance Manager, you will be responsible for overseeing and managing the Company’s quality assurance activities across incoming materials, warehouse operations, product release, quality systems, supplier qualification, documentation, and regulatory compliance. You will ensure that products, processes, and quality systems meet applicable Company standards, customer requirements, and regulatory requirements, including applicable FDA and cGMP requirements. You will work closely with Operations, Warehouse, Supply Chain, Regulatory, Sales, and other functions to maintain product quality, strengthen quality systems, and support continuous improvement. What you'll do Your responsibilities will include, but are not limited to, the following: Oversee day-to-day laboratory Quality Assurance activities and ensure compliance with established quality standards. Review and approve laboratory test results, COAs, specifications, and quality documentation. Ensure testing, sampling, and documentation activities are performed accurately and in accordance with approved procedures. Manage and maintain the laboratory Quality Management System (QMS). Develop, review, and approve SOPs, test methods, specifications, and other controlled documents. Oversee deviations, Out of Specification (OOS) results, non-conformances, CAPA, change controls, and quality investigations. Ensure laboratory records, data, and documentation are accurate, complete, and properly maintained. Monitor laboratory equipment calibration, maintenance, qualification, and related records, as applicable. Ensure compliance with applicable ISO-17025 requirements, FDA, cGMP, Company, and customer quality requirements. Lead and support internal, customer, supplier, and regulatory audits and inspections. Provide training, guidance, and oversight to laboratory and QA personnel. Identify quality risks and ensure timely investigation, escalation, and resolution of quality issues. Monitor QA and laboratory performance metrics and implement appropriate corrective or preventive actions. Drive continuous improvement of laboratory processes, testing practices, documentation, and quality systems. Perform other quality assurance, laboratory, and compliance-related duties as reasonably assigned by management. What you need Your responsibilities will include, but are not limited to, the following: Oversee day-to-day laboratory Quality Assurance activities and ensure compliance with established quality standards. Review and approve laboratory test results, COAs, specifications, and quality documentation. Ensure testing, sampling, and documentation activities are performed accurately and in accordance with approved procedures. Manage and maintain the laboratory Quality Management System (QMS). Develop, review, and approve SOPs, test methods, specifications, and other controlled documents. Oversee deviations, Out of Specification (OOS) results, non-conformances, CAPA, change controls, and quality investigations. Ensure laboratory records, data, and documentation are accurate, complete, and properly maintained. Monitor laboratory equipment calibration, maintenance, qualification, and related records, as applicable. Ensure compliance with applicable ISO-17025 requirements, FDA, cGMP, Company, and customer quality requirements. Lead and support internal, customer, supplier, and regulatory audits and inspections. Provide training, guidance, and oversight to laboratory and QA personnel. Identify quality risks and ensure timely investigation, escalation, and resolution of quality issues. Monitor QA and laboratory performance metrics and implement appropriate corrective or preventive actions. Drive continuous improvement of laboratory processes, testing practices, documentation, and quality systems. Perform other quality assurance, laboratory, and compliance-related duties as reasonably assigned by management. #J-18808-Ljbffr DBI360