QUALITY ASSURANCE SPECIALIST

Description

Job Summary: Abbott is seeking a Quality Assurance Specialist to evaluate exception reports and manage process changes related to Good Practices and associated risks. Key Highlights: 1. Meaningful work with professional development in an international company. 2. Being part of one of the world's most admired companies. 3. Managing exception reports and risks in quality assurance. **About Abbott** Abbott is a global healthcare leader that creates innovative science to improve people's health. We are always looking ahead, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do meaningful work, grow and learn, take care of yourself and your family, be authentically you, and live a full life. You will have access to: * Professional development with an international company where you can build the career you dream of. * A company recognized as a top workplace in dozens of countries worldwide and named one of the world's most admired companies by Fortune. * A company recognized as one of the best large workplaces, as well as a top workplace for diversity, working mothers, women executives, and women scientists. **The Opportunity** This position is located at the **LINCE** site within the EPD (Established Pharmaceuticals) division. Our broad portfolio of high-quality, differentiated-brand generic medicines spans multiple therapeutic areas, including gastroenterology, women's health, cardiometabolic, pain management / central nervous system, and respiratory. As a **Quality Assurance Specialist**, you will be responsible for evaluating and reviewing generated exception reports and/or managing changes across all processes related to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Storage Practices (GSP), as well as managing and evaluating risks associated with these processes. **ORGANIZATIONAL RELATIONSHIPS:** **REPORTS TO:** Head of Quality Assurance **COORDINATES WITH:** All Department Heads within Operations Management, Quality Management, and Research & Development Management. **What You’ll Do:** * Review generated exception reports to ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Storage Practices (GSP), and corporate policies. * Evaluate and review risk management to ensure data is generated demonstrating that the risk has been analyzed, assessed, controlled, communicated, and reviewed. * Manage the various phases of each Exception Report within the SOLTRAQ system. * Review and approve modification requests related to CAPAs originating from Exception Reports and Risk Management. * Monitor the manufacturing program and sampling of bulk and finished products according to the production schedule. * Verify and/or perform appearance controls and/or inspections of bulk and finished products as applicable. * Verify withdrawal of product retention samples according to established quantities. * Review planned change proposals and resulting action plans to ensure documentation is appropriate and complete. * Manage approval or rejection of change proposals prior to implementation. * Verify that all requirements established for implementing a change have been completed before the change is considered closed. * Evaluate and review risk management to ensure data is generated demonstrating that the risk has been analyzed, assessed, controlled, communicated, and reviewed. * Manage the various phases of Change Management within the SOLTRAQ system. * Review and approve modification requests related to CAPAs originating from Change Controls and Risk Management. * Follow up on observations identified during plant walkthroughs and documentation errors detected during production processes to improve the regional RFT (Right First Time) indicator. * Monitor the manufacturing program and sampling of bulk and finished products according to the production schedule. * Verify and/or perform appearance controls and/or inspections of bulk and finished products as applicable. * Verify withdrawal of product retention samples according to established quantities. * Generate indicators for plant walkthroughs and documentation errors in production processes. **Required Qualifications** * **EDUCATION:** Licensed Pharmaceutical Chemist * Minimum 3 years of experience in Quality Assurance or similar roles. * Knowledge of Soltraq is desirable. * Willingness to work at the Lince facility. * Monday to Friday, 8:30 AM – 6:00 PM **Apply Now** Follow your professional aspirations with Abbott to explore diverse opportunities with a company that can help you build your future and live your best life. Abbott is an equal opportunity employer committed to workforce diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews and @AbbottGlobal. **Abbott is an equal opportunity employer and conducts recruitment, selection, and hiring based solely on job-related qualifications, without regard to race, color, religion, creed, age, sex, national origin, gender identity or expression, sexual orientation, disability, marital status, veteran or military status, genetic information, citizenship status, or any other protected characteristic under applicable law.**