QA Manager

Quality Assurance Manager directs and improves the laboratory's quality systems and regulatory compliance. Responsible for coordinating the Quality Management System with input from the Laboratory Director, Laboratory Manager, group leaders, and staff; overseeing document control and quality records, training documentation, internal and external audits, corrective and preventive actions, proficiency testing scheduling and reporting, supplier qualification and traceability, and archival of GLP study records. Ensures annual internal audits, prepares regulatory or client reports (e.g., FDA/ODA data packages), verifies method validations and improvements for compliance with OMIC policies and regulatory requirements, writes and maintains QMS SOPs, conducts procedural audits against SOPs and regulatory standards, and produces periodic performance reports with recommendations for improvement. Coordinates annual Quality Review Meetings, calibration maintenance, and QA training; supports sales/marketing on QA-related inquiries. Supervises QA Associate/Assistant, participates in hiring/training, and upholds laboratory operations with attention to quality and compliance; requires a Bachelor’s degree in Chemistry or related field and 2 years QA regulatory experience; strong analytical, written communication, and MS Office skills; registered QA professionals (RQAP/RQAP-GLP) preferred.