Quality Assurance Associate

Quality Assurance Associate (GMP / Aseptic Manufacturing) – 6 Month Contract

📍 Bern, Switzerland

🏢 Multinational specialty biotechnology company

A multinational specialty biotechnology company is currently seeking a Quality Assurance Associate to support their aseptic manufacturing operations at their site in Bern.

This is a 6-month contract position offering the opportunity to work within a highly regulated pharmaceutical manufacturing environment and contribute to ensuring GMP compliance and product quality.

Key Responsibilities

• Provide QA support and guidance to aseptic manufacturing operations and microbiological laboratories
• Ensure compliance with GMP requirements within production processes
• Review and verify manufacturing documentation and production steps
• Participate in process reviews within aseptic manufacturing
• Support training and (re)qualification of production personnel
• Provide QA oversight during manufacturing activities and assist with risk assessments and compliance questions
• Manage deviations related to aseptic filling, including:
  • Initial deviation assessments
  • Supporting investigation strategies
  • Reviewing technical assessments
  • Supporting definition of corrective and preventive actions (CAPAs)
• Review investigation reports in German and English, ensuring compliance and appropriate risk evaluation
• Support internal and external inspections related to deviation management
• Assist with the review of procedural and quality documentation

Qualifications & Experience

• Degree in Life Sciences, Biotechnology, Pharmacy, Chemistry, or a related scientific field (Bachelor, Master, or PhD)
• Experience or knowledge of GMP within the pharmaceutical or biotechnology industry is advantageous
• Strong analytical thinking and problem-solving abilities
• Ability to review and critically assess technical documentation and reports
• Strong communication and teamwork skills, with the ability to interact across different organizational levels
• Ability to manage multiple tasks and changing priorities in a fast-paced environment
• High level of independence and initiative

Language Requirements

• Native-level German
• Very good English (written and spoken)