QC Empower Specialist at Boudry, Neuenburg

QC Empower Specialist

Temporary contract – 7 months (ASAP)

Location: Canton of Neuchâtel

Your role

As a QC Empower Specialist, you are responsible for the creation, configuration, maintenance, verification, and deployment of Custom Fields Calculations within Waters Empower. You will support current and future analytical methods by ensuring Custom Fields are correctly designed, verified, and implemented to meet laboratory and business needs in a dynamic GMP environment, with a strong focus on compliance and data integrity.

Your responsibilities

• Create, configure, maintain, and deploy Custom Fields Calculations within Waters Empower
• Translate analytical method requirements into robust Empower Custom Field configurations (calculations, reporting, product-specific needs)
• Execute and document functional verification activities to confirm Custom Fields perform as intended
• Perform verification testing to ensure Custom Fields support analytical workflows, calculations, reporting requirements, and method needs
• Support lifecycle management, harmonization and standardization of existing Custom Fields across products/methods
• Maintain GMP documentation related to Empower configuration activities and master data changes
• Ensure compliant management of Empower master data and Custom Field configurations
• Work autonomously, managing priorities effectively in a fast-paced environment
• Promote safe practices; report EHS incidents immediately, participate in investigations, and propose preventive actions
• Perform other tasks as assigned

Your profile

You are an autonomous, detail-oriented QC systems specialist with advanced Waters Empower expertise, able to work independently and document work to GMP standards. You learn quickly, communicate clearly, and are comfortable in a changing environment.

• Education: Federal Certificate of Capacity as Laboratory Technician or BS in Life Science, Chemistry, or equivalent (or equivalent combination of education and experience)
• Experience: Minimum 4 years of relevant experience, preferably in a regulated pharmaceutical environment
• Required: Advanced hands-on experience with Waters Empower software (super user level)
• Strong IT/software skills (MS Office: Word, Excel, PowerPoint, Outlook)
• Ability to convert analytical method needs into Empower Custom Field calculations/configuration
• Strong analytical and problem-solving skills; continuous improvement mindset
• Ability to work independently with limited supervision; strong time management and attention to detail
• Communication: Good verbal communication and strong technical writing skills
• Languages: Fluent in English or French; professional command of the second language (written and spoken)

Nice to have

• Knowledge of pharmaceutical QC laboratory operations and laboratory data management
• Experience with laboratory computerized systems; chromatography knowledge (LC/GC)
• Understanding of GMP-regulated environments
• Knowledge of 21 CFR Part 11 and/or GAMP
• Strong Data Integrity knowledge, including audit trail review expectations
• Previous experience with laboratory equipment qualification (preferred)