QC Associate Scientist / ta-330
For our customer located in Neuchatel / Switzerland we are currently looking for a : QC Associate Scientist (m / f / d)
Tasks & Responsibilities
Duties
The job holder is accountable for life cycle management activities of analytical assays performed in the QC Laboratories of Neuchâtel Switzerland with a focus on :
- Laboratory Investigations
- Critical Material Qualification
- Laboratory Method Transfers
In addition, the job holder also supports daily QC activities following cGMP, Pharma policies and EHS requirements.
Validation and Qualification Activities
- Author transfer protocols and reports for assays
- Author qualification plans and reports for critical reagents
- Oversee validation and qualification activities executed by analysts, provide training and support
- Execute and documents experiments
I nvestigation Leads
- Investigate and trouble shoot problems which occur to determine solutions or recommendations for improvements or change
- Conduct / participate in risk assessments, root cause analysis and investigations
- Own Laboratory Investigations and CAPA
Quality Control Support Activities
Support the application of industry specific compliance standards / regulations to assays life cycle management activitiesParticipate to daily activities upon request (provide technical and statistical support)
Must Haves
Experience
- University or engineering degree in analytical chemistry, biotechnology, biochemistry
- 1 or 2 years of experience in GMP pharma business activities, preferably in the scope of recombinant therapeutic product in pharmaceutical environment
- Experience in GMP Laboratory activities
- Good knowledge of method transfer
- Good knowledge of critical reagent qualification
- Experience in problem solving and deviation management
- Good Knowledge of statistical tools
- Fluent in French and English (C1 written and spoken)
- Proficiency in all aspects of standard IT tools
Competencies
- Excellent collaboration skills and teamwork mindset
- Good trouble shooting and problem-solving skills
- Ability to work independently in a fast-paced environment
- Ability to manage multiple priorities and know when to escalate issues for resolution
- Effective communicator
- Demonstrated ability to synthesize information
- Demonstrated ability to give and receive feedback