QC Chemist I

Responsible for performing routine analytical testing of raw material, in-process samples, finished products to ensure they meet quality standards and regulatory requirements. Understanding of regulatory compliance, quality management systems and document control processes, and the ability to collaborate cross-functionally and communicate effectively. Perform activities related to periodic audit trail review of all quality softwares, ensure compliance within the systems etc. Maintaining regulatory compliance in accordance with cGMP and Perform Data Integrity risk assessment of current Good Manufacturing Practices (cGMP) and GLP systems both manual and automated. Follow all safety procedures and guidelines to ensure a safe laboratory environment. Prioritize risks and work with IT, QA, laboratory personnel to mitigate data integrity gaps. Partnering with other members of the Quality Assurance team and/or end users of the system to Identify, Develop, and Implement Continuous Improvements to the Change Control System, Process, and associated procedures. Evaluate proposed and existing software systems that support laboratory and software applications for data integrity gaps. Works with IT and QA to resolve those gaps. Develop standard operating procedures for the administration of analytical and QC equipment. Ensuring the GMP status and the functionality of the laboratory equipment in accordance with the guidelines 21 CRF Part 11 on data integrity.