Cipla - Fall River, MA
posted 3 months ago
The Quality Assurance (QA) Analyst I position at InvaGen Pharmaceuticals, a subsidiary of Cipla, is a critical role that requires a strong background in analytical chemistry and laboratory practices. This individual contributor role is based in Fall River, Massachusetts, and reports directly to the Quality Assurance Manager. The primary purpose of this position is to ensure compliance with established protocols and regulations within the pharmaceutical manufacturing environment. The QA Analyst will be responsible for confirming the compliance of method validations, monitoring adherence to current Good Laboratory Practices (cGLP), and verifying standard operating procedures (SOPs) and test procedures. In this role, the QA Analyst will coordinate with the Regulatory Affairs and Analytical Laboratory Teams to ensure timely submission of required documents for new and existing abbreviated new drug applications (ANDAs). The position also involves maintaining proper tracking, recording, storage, and archival of all incoming documents. The QA Analyst will actively participate in laboratory investigations and incidents, ensuring compliance and identifying gaps within the system during routine monitoring. Additionally, the role includes conducting random internal audits in the analytical lab and assessing compliance related to raw materials, in-process, and finished product analytical documents. The QA Analyst will also be responsible for implementing changes related to Pharmacopoeia updates and performing other departmental and cross-functional projects as assigned by the manager. This position requires a proactive approach to quality assurance, with a focus on continuous improvement and adherence to regulatory standards.