Fisher Clinical Services GmbH
Lead QC Technician(m/w/x)
Vollzeitnur vor OrtSenior
Lengnau
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
THThermo Fisher Scientific
Senior Scientist, Material Qualification & Release (QC GMP)(m/w/x)
Lengnau
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Thermo Fisher Scientific erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- Thermo Fisher Scientific Inc.
Senior Requalification Engineer(m/w/x)
Vollzeitnur vor OrtSeniorLengnau - Thermo Fisher Scientific
Scientist Bio-/Chemical Quality Control(m/w/x)
Vollzeitnur vor OrtBerufseinsteigerLengnau - Thermo Fisher Scientific
Senior Scientist – Manufacturing Science & Technology (Biologics USP/DSP)(m/w/x)
Vollzeitnur vor OrtSeniorLengnau - SIEGFRIED DiNAMIQS AG
QA Specialist(m/w/x)
Vollzeitnur vor OrtSeniorSchlieren
THThermo Fisher Scientific
Senior Scientist, Material Qualification & Release (QC GMP)(m/w/x)
Lengnau
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Thermo Fisher Scientific erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Thermo Fisher Scientific
Branche
Pharmaceuticals
Beschreibung
The company enables customers to make the world healthier, cleaner, and safer through innovative scientific solutions.
Noch nicht perfekt?
- Fisher Clinical Services GmbH
Lead QC Technician(m/w/x)
Vollzeitnur vor OrtSeniorLengnau - Thermo Fisher Scientific Inc.
Senior Requalification Engineer(m/w/x)
Vollzeitnur vor OrtSeniorLengnau - Thermo Fisher Scientific
Scientist Bio-/Chemical Quality Control(m/w/x)
Vollzeitnur vor OrtBerufseinsteigerLengnau - Thermo Fisher Scientific
Senior Scientist – Manufacturing Science & Technology (Biologics USP/DSP)(m/w/x)
Vollzeitnur vor OrtSeniorLengnau - SIEGFRIED DiNAMIQS AG
QA Specialist(m/w/x)
Vollzeitnur vor OrtSeniorSchlieren