The QA Specialist, Manufacturing Investigations reports to the Manager of QA Investigations and is responsible for activities related to the investigations/deviations/CAPA process. Responsibilities include conducting the investigations, implementing appropriate corrective actions and verifying effectiveness of CAPA. Additional responsibilities includes administrative and compliance support to the Quality department within the Lupin Somerset facility.
Write, and at times review, deviations related to manufacturing, packaging, warehouse, facility and engineering, etc.
Gather quantitative and qualitative data from various areas of operation for analysis (i.e., manufacturing floor, warehouse, etc.)
Provide review of investigation reports and supportive documentation (including data) for accuracy and completeness, where needed.
Aid and/or Conduct Root Cause Analysis (RCA) to evaluate each of the possible causes in order to determine the true root cause.
Propose, review and/or implement appropriate corrective actions and preventive actions (CAPA) based on the investigations
Perform Risk Analysis on the product disposition and involve MRB (Material Review Board) where necessary.
Verify the CAPA effectiveness periodically and modify the CAPA accordingly.
Organize and maintain files, maintain document templates; track document activities/status.
Develop and track meaningful investigations/CAPA metrics for management review and conduct periodic reporting on metrics and trends.
Assist management in filing FAR (Field Alert Report) to FDA and during FDA audits with respect to investigations and CAPA.
Assist in the development of policies, procedures and protocols for investigation-related practices.
Review current SOP’s, policies and systems with respect to quality documentation, modify and improve as necessary.
Attend training courses as necessary.
Perform other activities as required by the Compliance department
Bachelor’s degree in an engineering, scientific, or statistical field.
Expert knowledge of manufacturing processes and operations
5+ years’ experience in pharmaceutical industry, preferably in Quality Assurance / Quality Control investigations.
Working knowledge of root cause analysis tools
Excellent technical writing skills
Working knowledge of QAMS
Prior experience with FDA audits is a plus
Working knowledge of Microsoft Word, Excel and PowerPoint is necessary
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 20 pounds occasionally. Generally work is performed in an office and or manufacturing environment.
Lupin Somerset is an operating division of Lupin, which is among the top performing global generic pharmaceutical companies. Lupin Somerset is located in central New Jersey and is the first manufacturing facility in the United States for Lupin. There are approximately 400 employees in the Somerset, New Jersey division working in all functional areas including Research & Development, Manufacturing..., Packaging, Warehouse, Finance and Accounting, Human Resources, Regulatory Affairs, Information Technology, Quality Control, Compliance, and Quality Assurance.