Thermo Fisher Scientific
Senior Scientist, Material Qualification & Release (QC GMP)(m/w/x)
Vollzeitnur vor OrtSenior
Lengnau
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FIFisher Clinical Services GmbH
Lead QC Technician(m/w/x)
Lengnau
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Product testing and inspection in a cGMP environment for life science solutions, leading a team of QC technicians. 4 years QC experience in regulated pharma/med device environment, with analytical testing equipment proficiency, required. Leadership role in critical quality function.
Anforderungen
- Minimum 4 years quality control experience in regulated environment (pharmaceutical/medical device preferred)
- Preferred fields of study: Chemistry, Biology, or related scientific field
- Proficiency with analytical testing equipment and techniques (HPLC, GC, spectrophotometry)
- Strong understanding of cGMP requirements and quality systems
- Experience with quality documentation and data review
- Ability to lead and mentor others while maintaining quality standards
- Excellent attention to detail and organizational skills
- Strong verbal and written communication abilities
- Proficiency with standard office software and LIMS systems
- Ability to work in cleanroom environments and follow gowning procedures
- Physical ability to stand for extended periods, lift up to 25 lbs occasionally
- Flexibility to work various shifts
- Problem-solving and technical troubleshooting skills
- Experience writing and reviewing SOPs and technical documentation
Aufgaben
- Conduct product testing and inspection in a cGMP environment.
- Coordinate quality control activities.
- Lead a team of QC technicians.
- Collaborate with cross-functional teams to maintain quality standards.
- Perform analytical testing.
- Document testing results.
- Support continuous improvement initiatives.
- Mentor team members.
- Organize daily MBQC laboratory operations.
- Maintain MBQC laboratory equipment and operations.
- Create and revise guidance documents like SOPs/WIs.
- Serve as Subject Matter Expert for Bioburden, Growth Promotion, Micro Identifications, and Endotoxin testing methods.
- Provide expertise on quality events related to these methods.
- Participate in microbiological method transfer, development, verification, and validation.
- Qualify equipment for microbiological analysis.
- Perform backup testing for final, intermediate, and in-process products.
- Perform backup testing for cleaning validation samples.
- Perform backup testing for utility and environmental monitoring samples.
- Support QC GMP inspection readiness to ensure document compliance.
- Support QC teams with material ordering, sample logistics, and inventory management.
- Act as Biosafety Officer at the Lengnau site, adhering to Swiss law.
Berufserfahrung
- 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- HPLC
- GC
- spectrophotometry
- LIMS systems
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Fisher Clinical Services GmbH 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.
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FIFisher Clinical Services GmbH
Lead QC Technician(m/w/x)
Lengnau
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Product testing and inspection in a cGMP environment for life science solutions, leading a team of QC technicians. 4 years QC experience in regulated pharma/med device environment, with analytical testing equipment proficiency, required. Leadership role in critical quality function.
Anforderungen
- Minimum 4 years quality control experience in regulated environment (pharmaceutical/medical device preferred)
- Preferred fields of study: Chemistry, Biology, or related scientific field
- Proficiency with analytical testing equipment and techniques (HPLC, GC, spectrophotometry)
- Strong understanding of cGMP requirements and quality systems
- Experience with quality documentation and data review
- Ability to lead and mentor others while maintaining quality standards
- Excellent attention to detail and organizational skills
- Strong verbal and written communication abilities
- Proficiency with standard office software and LIMS systems
- Ability to work in cleanroom environments and follow gowning procedures
- Physical ability to stand for extended periods, lift up to 25 lbs occasionally
- Flexibility to work various shifts
- Problem-solving and technical troubleshooting skills
- Experience writing and reviewing SOPs and technical documentation
Aufgaben
- Conduct product testing and inspection in a cGMP environment.
- Coordinate quality control activities.
- Lead a team of QC technicians.
- Collaborate with cross-functional teams to maintain quality standards.
- Perform analytical testing.
- Document testing results.
- Support continuous improvement initiatives.
- Mentor team members.
- Organize daily MBQC laboratory operations.
- Maintain MBQC laboratory equipment and operations.
- Create and revise guidance documents like SOPs/WIs.
- Serve as Subject Matter Expert for Bioburden, Growth Promotion, Micro Identifications, and Endotoxin testing methods.
- Provide expertise on quality events related to these methods.
- Participate in microbiological method transfer, development, verification, and validation.
- Qualify equipment for microbiological analysis.
- Perform backup testing for final, intermediate, and in-process products.
- Perform backup testing for cleaning validation samples.
- Perform backup testing for utility and environmental monitoring samples.
- Support QC GMP inspection readiness to ensure document compliance.
- Support QC teams with material ordering, sample logistics, and inventory management.
- Act as Biosafety Officer at the Lengnau site, adhering to Swiss law.
Berufserfahrung
- 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- HPLC
- GC
- spectrophotometry
- LIMS systems
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Fisher Clinical Services GmbH 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
Fisher Clinical Services GmbH
Branche
Science
Beschreibung
Das Unternehmen ist marktführend in den Bereichen Clinical Supply Chain Management Services und Clinical Supplies für Patienten weltweit.
Noch nicht perfekt?
- Thermo Fisher Scientific
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