Quality Senior Analyst

Kenvue is currently recruiting for: 
                
Quality Senior Analyst
This position reports into Senior Manager Microbiological Quality & Sterility Assurance, EMEA and is preferably based in Madrid.
 
Who we are
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here. 
                

What you will do
The Quality Senior Analyst management representative with the responsibility and authority of ensuring that the appropriate Kenvue’s microbial contamination control programs associated with continued product and portfolio reliability, infection prevention and introduction of rapid technology are implemented and maintained for Kenvue operations across the Southern Europe Cluster, with incidental support to other countries, as per business needs.
The Quality Senior Analyst will also be responsible for supporting the R&D, Pilot Plant, MQSA-NPI/NPD and QHS teams in the development and transfer of scaled-up microbiologically controlled processes.

Key Responsibilities

• Responsible for supporting the characterization efforts of the large-scale manufacturing processes ensuring a successful scale-up and transfer from lab-scale/pilot plant to the commercial manufacturing facilities and qualification of sites to meet product design at the indicated geographical areas.
• Championing proactive quality through process design in alignment with design for microbiological controlled manufacturing principles, approval of transfers from pilot stages to scale-up, approval of MQSA technical documents and activities to improve technical attributes of product performance, compliance, and reliability enabling rapid microbiological technologies and process analytical technologies.
• Responsible in defining and developing microbial control critical process parameters to meet product CQAs at scale-up.
• Support root cause analysis and CAPA determination associated with technical product investigations, including accountability to proactively identify and deploy CAPAs proven effective investigations associated with manufacturing design.
• Active involvement in the maintenance of suppliers through MRAS and qualification of direct material suppliers, support MRAS as part of production life cycle, approval of change controls prior to the adoption of new suppliers in the commercial manufacturing environment and material source changes.
• Support internal and external manufacturing audit assessments to include suppliers.
• Maintain sterilization and microbial reduction technologies (where applicable) and assist in the preparation of protocols and technical reports.
• Responsible for microbially control process design including cleaning and sanitization to support manufacturing requirements (e.g., campaign manufacturing), and approve technical reports generated from compliance programs (e.g. regulatory inspections, regulatory commitments, and global non-conformances and CAPAs among others).
• Support Commercial Quality and distribution Organizations in the evaluation of product impact associated to distributed product (e.g., marketed product stability, potential field actions, etc.).
• Process ownership of one or more assigned Kenvue programs associated with continued product and portfolio reliability, compliance, and/or performance.
• Conduct training for laboratory, and management personnel, as needed, to support the implementation of microbiological quality and sterility assurance practices.
• Provide support during due diligence for acquisitions and integration