São José dos Campos, BRA
6 days ago
Quality Assurance Analyst
At Johnson & Johnson,  we believe health is everything. Our strength in healthcare innovation empowers us to build a  world where complex diseases are prevented, treated, and cured,  where treatments are smarter and less invasive, and  solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong. We are searching for the best talent for Quality Assurance Analyst to be in Sao Jose dos Campos, Brasil. Purpose: The JnJ Quality Analyst will be able to manage quality excellence activities. You will be responsible for: + Oversee and manage quality-related processes, including controlled substances, site metrics, gap assessments, documentation review. + Projects management, ensuring that quality standards are maintained and that all deliverables are met on time and within scope, including proactive risk management and collaboration with stakeholders to ensure successful project execution. + Control and monitor Quality Key Performance Indicators (KPIs) to ensure continuous improvement and compliance with internal and external standards. + Perform gap assessments of policies and legislation to ensure local procedures align with GxP (Good x Practice) requirements. + Coordinate and manage the controlled substances process, ensuring compliance with relevant regulations. + Oversee access control processes within the site to maintain security and compliance. + Collaborate with cross-functional teams to drive quality initiatives and improvements. **Qualifications** Qualifications: + Bachelor's degree in Pharmacy, Engineering, or a related field. + 3 to 5 years of experience, preferably in the pharmaceutical or related industries (e.g., medical devices) + In-depth understanding of pharmaceutical legislation, including RDC 658/2022, Portaria 344/98, and other relevant GxP regulations. + Excellent communication skills, capable of effectively interacting with all levels of the organization. + Proven ability to work collaboratively in a team environment. + Commitment to quality and continuous improvement. + Proficiency in English (spoken, written, and listening). Desirable: + Experience with statistical techniques and data analysis tools (Power BI, Minitab, Tableau). + Experience in project management, including the use of tools (e.g., MS Project)
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