
Senior Laboratory Scientist
2 days ago
The successful candidate will lead a team of lab technicians and guide them on technical tasks and projects.
Key Responsibilities:
- Develop, validate, and improve laboratory test methods (such as bioassays and mycoplasma testing).
- Review and approve test results for both accredited and non-accredited tests.
- Analyze laboratory data and provide scientific conclusions.
- Act as a subject matter expert (SME) and ensure compliance with all regulatory standards.
- Communicate directly with customers about technical matters and attend site visits if needed.
- Write and update laboratory documents (methods, SOPs, protocols, reports, etc.).
- Ensure laboratory procedures meet all regulatory and quality requirements.
- Troubleshoot technical problems and support investigations.
- Report any compliance issues to Quality Assurance and Senior Management.
- Monitor and manage laboratory performance testing and ensure ongoing compliance.
- Participate in audits (internal, external, regulatory) and regular management reviews.
- Lead improvements in processes, quality, and safety within the laboratory.
Requirements:
- Minimum Bachelor's degree in Science or a related field.
- Minimum 2 years of hands-on experience in microbiology testing in an ISO17025/GMP laboratory.
- Experience in method development, validation, transfer, and qualification.
- Strong knowledge of ISO 17025, cGMP, and other relevant regulations.
- Understanding of project management and measurement uncertainty is a plus.
- Good technical judgment and problem-solving skills.
- Strong communication skills, especially across different cultures.
- Able to work well both independently and as part of a team.
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