| Our Culture At Boehringer Ingelheim, we deliver Value through Innovation by living our fundamental principles of Lead & Learn. We have high expectations for our employees. We require employees at all levels of the organization to take initiative, stay connected, grow together, and achieve outstanding results. To enable high performance, we provide opportunities for personal growth, a collaborative and inclusive work environment, and exceptional employee benefits. We reward high achievement with recognition, opportunities and competitive pay. We hold ourselves to the highest standard of excellence and count on each other to go the extra mile in everything we do.
Quality Systems Specialist
Position Summary: The specialist is responsible for investigating quality issues and reviews the results of manufacturing investigations. Responsible for deviation investigations, out of specification results and atypical results investigations and associated corrective and preventive actions (CAPA). Duties and Responsibilities:
Investigates events to gather relevant information necessary to develop investigation. Ensures that reports are aligned with regulatory requirements, site standard procedures and company policies.
Reviews protocols, analytical results and/or documents associated with investigations. Ensures the compliance with regulations for the quality of the investigations, the identification of the root cause, the identification of the appropriate correctives and preventative actions, and the product impact and disposition. Assists with the development of CAPAs and collaborate with stakeholders to ensure that all necessary activities are executed timely and effectively.
Interface with contract customer representatives to notify of process/product exceptions and determine responsibilities and solutions related to the event.
Support Domestic and International Regulatory inspections, preparations and corrective actions as needed.
Representing Quality Assurance at various project and technical meetings, as needed.
Assist in developing and maintaining various quality systems and programs, as needed.
Requirements:
Requires a Bachelor of Science or other related technical discipline
At least 3 years of experience in a pharmaceutical/ drug (FDA regulated) industry.
At least 1 year of experience with 21 CFR 820 Quality System Regulations or ISO standards
At least 1 year of experience in aseptic manufacturing or auditing of aseptic processes.
Experience in risk management preferred.
Six Sigma Experience and/or knowledge preferred.
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