Contractor QC Associate Scientist (f/m/d)

Industry: Biotech
Skills: Quality Control,Validaton,qualification,cGMP,Investigation

Start of project: 01.04.2024

Duration of the project : 6 months

Project volume: 1008 Hour(s) 

Location: Neuchâtel, Switzerland

Responsibilities:

The incumbent is responsible for overseeing various life cycle management tasks related to analytical assays conducted within the QC Laboratories of a Swiss-based company, focusing on:

• Conducting Laboratory Investigations
• Qualifying Critical Materials
• Facilitating Laboratory Method Transfers

Moreover, the role entails supporting daily QC operations in alignment with cGMP, company policies, and Environmental Health and Safety (EHS) standards.

Activities in Validation and Qualification:

• Drafting transfer protocols and reports for assays
• Developing qualification plans and reports for critical reagents
• Supervising validation and qualification activities carried out by analysts, providing guidance and training
• Conducting and documenting experiments

Leading Investigations:

• Investigating and troubleshooting issues to identify solutions or recommendations for enhancements or changes
• Participating in risk assessments, root cause analyses, and investigations
• Taking ownership of Laboratory Investigations and Corrective and Preventive Actions (CAPA)

Supporting Quality Control:

• Assisting in applying industry-specific compliance standards and regulations to life cycle management activities for assays
• Participating in daily activities as needed, offering technical and statistical support

Experience:

• Bachelor's or Master's degree in analytical chemistry, biotechnology, or biochemistry
• 1-2 years of experience in GMP pharmaceutical operations, preferably in the realm of recombinant therapeutic products within a pharmaceutical setting
• Proficiency in GMP laboratory practices
• Strong understanding of method transfer and critical reagent qualification
• Experience in problem-solving and deviation management
• Familiarity with statistical tools
• Fluency in both French and English (written and spoken at C1 level)
• Competency in standard IT tools

Competencies:

• Excellent collaboration and teamwork skills
• Strong troubleshooting and problem-solving abilities
• Capacity to work independently in a dynamic environment
• Ability to manage multiple priorities and escalate issues when necessary
• Effective communication skills
• Demonstrated aptitude for synthesizing information

Openness to giving and receiving feedback