Quality Assurance Specialist

Curia is a global CDMO with over 30 years of experience successfully guiding clients through the complexities of drug discovery, development, and manufacturing. We offer services across Small Molecules, Generic APIs, and Biologics backed by deep scientific expertise and a robust global network of resources and capabilities. Our dedicated teams, combined with advanced technologies, enable us to be both flexible and scalable, accelerating the delivery of your product to patients. This role is based out at Global Shared Services Center. Curia’s Global Shared Services Center (GSS) is a multi-functional strategic service center that delivers word class business support services to Curia and its consolidated subsidiaries. In this Role Associate would be responsible for supporting the team on operations activities related to environmental monitoring and utilities reports per the deliverables/mandates. The individual hired will be expected to foster an environment of continuous improvement and assist/participate in initiatives that enhance operational efficiency and control. Responsibilities : Review, analyze and/or interpret data to generate the related documents and reports. Perform activities related to Environmental monitoring and utilities reports. Data trending: Collect data, use statistical tools (excel, other tools), calculate trends. Tracking: Use calendar, schedules by sites and ensure the Trend reports are made ready. Report drafting: Use templates and prepare reports for review to the senior associates or to the team manager. Alert level assessment reports to be prepared and reviewed. Water and Utility reports preparations and reviewed. Aseptic process and sterility assurance knowledge and other critical areas related to Microbiology. Manage deadlines with efficiency and a high level of accuracy, manage multiple deadlines and communicate concerns as deemed necessary. Follows Curia Quality policies and procedures. Ability to follow manuals and FDA and ISO guidelines for sterility assurance. Results Focus. Qualifications : B.S./B.A. or M.S. degree in Biology, Microbiology, Biotechnology or related field. 7-10 years of experience in the pharmaceutical industry (commercial manufacturing facilities within API and/or DP), with experience in Microbiology Quality Assurance. Experience of Shared Services strongly preferred (dedicated unit for the execution of specific operational tasks for the multiple business units within the organization). Strong knowledge of the pharmaceutical industry regulations applicable to API and Drug Product manufacturers. Have experience with qualifying, monitoring and/or gowning into classified Cleanroom areas. Have experience with Barrier/Isolator Technology. Are familiar with Compendial Testing (Bioburden, Endotoxin, etc.). Are familiar with Aseptic Techniques and cGMP practices. Good understanding on Good Manufacturing Practices, with practical experience on the field. Required Skills : Strong analytical skills, attention to detail, and the ability to work under pressure while managing multiple deadlines. Preferred Skills : Experience with statistical tools and familiarity with regulatory compliance in the pharmaceutical industry. Show more Show less