Quality & Compliance Intern: QMS & Documentation

Fresenius Kabi USA; Eysins; On-site; CHF 90,000 - 130,000; Full time

Job summary

Fresenius Kabi USA seeks a Quality Documentation Specialist to support the QMS and compliance activities within the Biopharma Quality organization. You will assist with documentation processes, training, and continuous improvement initiatives to ensure regulatory alignment.

Key tasks include acting as the eDMS key user and trainer, coordinating SOPs, guidelines, and archived materials, and collecting KPI data while liaising with Production Units, Suppliers, and internal teams.

Qualifications

• Understanding of GMP principles and regulatory expectations.
• Excellent communication in English; French and German are an asset.
• Demonstrated ability to work effectively in a team.
• Excellent planning and organization skills, detail-oriented.
• Flexible to switch between projects.
• Ability to lead and synthesize meetings with internal and external parties.
• Goal orientation and follow-up.
• Interest in computerized systems and digitalization.
• Experience with Office 365 applications.

Responsibilities

• Act as eDMS key user and trainer for electronic Quality Management Tools.
• Collaborate with cross-functional teams to ensure timely execution of QMS deliverables.
• Support distribution and archiving of SOPs, Guidelines, Policies, Manuals, Working Instructions.
• Collect KPI data for periodic local QMS reviews; liaise with Business Units, Production Units, and Suppliers.
• Support continuous improvement of QMS processes related to Document Management, Inspection Readiness, Supplier Management, Change Control / Events, CAPAs.

Skills

GMP knowledge

English communication

Team collaboration

Planning & organization

Digitalization interest

Office 365

Meeting facilitation

eDMS familiarity

Education

Bachelor's degree in a scientific field

Tools

eDMS

Office 365

Job description

Fresenius Kabi USA seeks a Quality Documentation Specialist to support the QMS and compliance activities within the Biopharma Quality organization. You will assist with documentation processes, training, and continuous improvement initiatives to ensure regulatory alignment.

Key tasks include acting as the eDMS key user and trainer, coordinating SOPs, guidelines, and archived materials, and collecting KPI data while liaising with Production Units, Suppliers, and internal teams.