QUALITY ASSURANCE SR ANALYST

Quality Assurance Sr Analyst - Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. QUALITY ASSURANCE SR ANALYST - FIXED TERM 12 MONTHS - JANSSEN SJC Key Responsibilities:Be the quality representative in the New Project and properly address the needs to guarantee compliance in both JJ Standards and Regulatory requirements. Ability to read and interpret global documents and regulatory requirements and translate/reflect it at local operational SOPs and work instructions as appropriate. Identify and explore best practices to improve quality processes in support of Janssen Supply Chain areas. Oversee site audit preparation, readiness, and response (JJRC, HA inspections among others). Lead, Support and Approves quality records as required (not limited to). Investigations, CAPAs, change controls, risk assessments and changes to documentation and processes. Oversees the effective implementation and maintenance of Janssen QMS requirements, ensuring awareness and continuous education within the Quality Control and Supply Chain operation. Participate as atechnical resource and departmental representative on multi- Functional, interdepartmental teams. Independently makes appropriate and compliant GxP decisions and resolves problems using quality tools and advanced root cause analysis skills. Assure the quality tools / IT systems are used. Consolidate and track the quality compliance metrics as applicable. Identify, analyze and address gaps, recommend initiatives for continuous improvement and compliance enforcement. Support other activities/projects as required. QualificationsQualifications Education:University/bachelor''s degree in pharmacy, Engineering, or related areas. Requires 6- 8 Years Work Experience in a Quality Role within Pharmaceutical, Cosmetics, Food, Medical Device company (GMP controlled environment). Experience and Skills Required:Decisive, organized, and work within a complex environment. Ability to adapt to changing organizational and operational needs. Ability to lead others through change. Ability to handle multiple tasks simultaneously. Analytical, prioritization, and communication skills, with the ability to communicate with all levels of the organization. Strong team player and leader with the ability to work across multiple functions and disciplines. Ability to work in a fast- Aced environment and meet deadlines. Preferred:Previous Pharmaceutical industry experience. Previous experience collaborating with regulatory agencies, ANVISA, INVIMA, FDA, etc. Strong relationship development, conflict resolution, and team- Uilding instincts, with the ability to build partnerships both internally and externally. Other:**Language**:English advanced / fluent (speak, written and listening). No travel is required for this position.