Fisher Clinical Services GmbH
Lead QC Technician(m/w/x)
Full-timeOn-siteSenior
Lengnau
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THThermo Fisher Scientific
Senior Scientist, Material Qualification & Release (QC GMP)(m/w/x)
Lengnau
Full-timeOn-siteSenior
Nejo AI Summary
GMP-compliant release of raw materials and driving QC for material qualification. 5+ years GMP lab experience in pharma/biopharma required. On-site parking, 401(k) matching.
Requirements
- Bachelor's or Master's degree in Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or related scientific discipline
- Equivalent professional experience in GMP-regulated pharmaceutical or biopharmaceutical environment
- Minimum 5 years of experience in GMP laboratory within pharmaceutical or biopharmaceutical industry
- Demonstrated expertise in raw material qualification and release within GMP-regulated manufacturing environment
- Strong working knowledge of health authority expectations and regulatory compliance
- Proficiency in technical English (written and spoken)
- Strong commitment to quality, compliance, and data integrity
- Structured, risk-based mindset with high attention to detail
- Ability to work independently while collaborating cross-functionally
- Strong analytical thinking and problem-solving capabilities
- Excellent communication, organizational, and prioritization skills
- Interest in digitalization and modernization of analytical systems and QC processes
- Continuous learning mindset with motivation to further develop technical and regulatory expertise
Tasks
- Lead GMP-compliant release of raw materials
- Execute GMP-compliant release of raw materials
- Drive QC aspects of material qualification
- Ensure alignment with regulatory requirements
- Serve as SME for raw material analytics
- Provide expert support for deviations
- Provide expert support for OOS/OOT investigations
- Provide expert support for troubleshooting
- Provide expert support for continuous improvement
- Collaborate with internal laboratories
- Collaborate with external laboratories
- Ensure robust analytical execution
- Ensure data integrity
- Act as investigator for deviations
- Act as investigator for change controls
- Ensure timely resolution of deviations
- Ensure compliant resolution of deviations
- Author GMP-relevant documentation
- Review GMP-relevant documentation
- Maintain GMP-relevant documentation
- Conduct gap assessments
- Define remediation measures
- Implement remediation measures
- Support health authority inspections
- Support customer inspections
- Participate in health authority audits
- Participate in customer audits
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thermo Fisher Scientific and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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THThermo Fisher Scientific
Senior Scientist, Material Qualification & Release (QC GMP)(m/w/x)
Lengnau
Full-timeOn-siteSenior
Nejo AI Summary
GMP-compliant release of raw materials and driving QC for material qualification. 5+ years GMP lab experience in pharma/biopharma required. On-site parking, 401(k) matching.
Requirements
- Bachelor's or Master's degree in Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or related scientific discipline
- Equivalent professional experience in GMP-regulated pharmaceutical or biopharmaceutical environment
- Minimum 5 years of experience in GMP laboratory within pharmaceutical or biopharmaceutical industry
- Demonstrated expertise in raw material qualification and release within GMP-regulated manufacturing environment
- Strong working knowledge of health authority expectations and regulatory compliance
- Proficiency in technical English (written and spoken)
- Strong commitment to quality, compliance, and data integrity
- Structured, risk-based mindset with high attention to detail
- Ability to work independently while collaborating cross-functionally
- Strong analytical thinking and problem-solving capabilities
- Excellent communication, organizational, and prioritization skills
- Interest in digitalization and modernization of analytical systems and QC processes
- Continuous learning mindset with motivation to further develop technical and regulatory expertise
Tasks
- Lead GMP-compliant release of raw materials
- Execute GMP-compliant release of raw materials
- Drive QC aspects of material qualification
- Ensure alignment with regulatory requirements
- Serve as SME for raw material analytics
- Provide expert support for deviations
- Provide expert support for OOS/OOT investigations
- Provide expert support for troubleshooting
- Provide expert support for continuous improvement
- Collaborate with internal laboratories
- Collaborate with external laboratories
- Ensure robust analytical execution
- Ensure data integrity
- Act as investigator for deviations
- Act as investigator for change controls
- Ensure timely resolution of deviations
- Ensure compliant resolution of deviations
- Author GMP-relevant documentation
- Review GMP-relevant documentation
- Maintain GMP-relevant documentation
- Conduct gap assessments
- Define remediation measures
- Implement remediation measures
- Support health authority inspections
- Support customer inspections
- Participate in health authority audits
- Participate in customer audits
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thermo Fisher Scientific and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Thermo Fisher Scientific
Industry
Pharmaceuticals
Description
The company enables customers to make the world healthier, cleaner, and safer through innovative scientific solutions.
Not a perfect match?
- Fisher Clinical Services GmbH
Lead QC Technician(m/w/x)
Full-timeOn-siteSeniorLengnau - Thermo Fisher Scientific Inc.
Senior Requalification Engineer(m/w/x)
Full-timeOn-siteSeniorLengnau - Thermo Fisher Scientific
Scientist Bio-/Chemical Quality Control(m/w/x)
Full-timeOn-siteEntry LevelLengnau - Thermo Fisher Scientific
Senior Scientist – Manufacturing Science & Technology (Biologics USP/DSP)(m/w/x)
Full-timeOn-siteSeniorLengnau - SIEGFRIED DiNAMIQS AG
QA Specialist(m/w/x)
Full-timeOn-siteSeniorSchlieren