Manager, Quality Assurance
13 hours ago
Overview Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way. Responsibilities Lupin, Inc. - 400 Campus Drive, Somerset, New Jersey 08873 Title: Manager, Quality Assurance Duties: Lupin, Inc. seeks a Manager, Quality Assurance in Somerset, New Jersey to perform quality assurance and control activities for pharmaceutical manufacturing processes. Conduct site quality control and assurance and compliance activities for pharmaceutical manufacturing processes. Serve as the company liaison with FDA Recall Coordinator, FDA Complaint Coordinator, and FDA field offices for pharmaceutical products distributed by the company. Manage submission of field alert reports to the district office. Develop the methodology and filing ANDAs. Conduct deviation change controls and laboratory investigations. Utilize quality management software for laboratory quality events, including Caliber QAMS and TrackWise. Conduct supplier audits per the vendor management system for Active Pharmaceutical Ingredients, Excipients, primary packaging materials, and printed packaging materials. Support contract manufacturing and packaging of external projects, investigations of out of specification results, OOT, deviation, laboratory incidents, and product failures. Ensure that deviations, quality events, complaints are investigated and documented with corrective and preventive actions (CAPAs). Identify and implement CAPAs based on the result of complaint investigations. Oversee complaint management system for products manufactured by company and distributed in the United States. Manage distribution QA activities through support of data review and product release. Review quality agreements, negotiations, and execution. Annual salary: $125,341.00. Requirements: Master’s degree in Pharmaceutical Science, Pharmaceutical Manufacturing, or a related field plus one year of quality control experience. Must have at least one year of experience in each of the following: 1. Conducting site quality control and compliance activities for pharmaceutical manufacturing processes; 2. Ensuring that deviations and quality events and complaints are investigated and documented with corrective and preventive actions (CAPAs); 3. Identifying and implementing CAPAs based on the result of complaint investigations; 4. Developing the methodology and filing ANDAs; 5. Conducting deviation change controls and laboratory investigations; and 6. Utilizing quality management software for laboratory quality events, including Caliber QAMS and TrackWise.
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