Senior QA Specialist, Clean Utilities and Environmental Monitoring 80-100% (f/m/d)

Location: the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

The QA Specialist (QA On The Floor) is responsible to the Associate Director, Head of QA Operations BioAtrium  in joining a strong and innovative team that is perceived as a main contributor to the success of the large scale mammalian operations in our future BioAtrium site.  A great candidate will have strong GMP mindset, have leadership capabilities, envisioning and driving teamwork, quality culture, and innovation with the goal of becoming a role model within Lonza. We are looking for someone comfortable working in a matrix organization, effective with cross-functional projects, someone who can conceptualize where we need to be, how to get there, and drive ideas to completion.  The QA Specialist will within the QA Operations team as QA On The Floor, but will support other QA Ops teams (e.g. Clean Utilities and Environmental Monitoring, QA for QC and Electronic Batch Record Review) They will interact with the the other Operational teams at BioAtrium like Production, Engineering and Project Management. 

What you will get:

• An agile career and a dynamic work culture.

• An inclusive and ethical workplace.

• Compensation programs that recognize high performance.

In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found below.

Benefits in Visp: https://bit.ly/3wjkoFi  

What you will do:

• Comply with, Develop, implement and monitor quality procedures to ensure compliance with GxP standards, corporate policies, Swissmedic, FDA and other regulatory body regulations and guidelines.
• Support all QA operations activities concerning SOP landscape, electronic batch records, training,  deviation- / CAPA- and change control management
• Support all audits and inspections
• Identify and implement Lean / OPEX approaches in Quality and foster improvement projects
• Provide KPI reporting and execute action plans to address opportunities for improvement
• Work collaboratively with QA Operations and QA department colleagues

What we are looking for:

• Academic degree in a Life Science discipline/ Engineering/ Quality Management or related field
• Experience in working on a regulated Medical device, Drug product or Drug Substance site
• Experience with Lean / Operational Excellence / Six Sigma
• GMP compliance expertise
• Ability to interface and communicate directly with customers and regulatory bodies
• Excellent written and oral communication to include accurate and legible documentation
• Ability to work on call and/or out of normal working hours on site
• Fluency in English is required, German language skills are an advantage

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.