Manager Microbiological Quality Control, Lengnau
vor 6 Monaten
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
The state-of-the-art multi-purpose manufacturing facility is designed for large-scale production of biologics and has high expansion potential. After completion of construction activities, our site in Lengnau will offer highly flexible biomanufacturing technologies, from development to large-scale production including stainless steel equipment to meet our customer needs.
As a member of the Quality Control management team the position holder manages the Microbiology Unit (MBQC) at Thermo Fisher, Lengnau site according to project timelines and future routine demands.
**Your responsibilities**:
- Ensure the continued update of the operational procedures related to the QC area to align with the latest quality requirements
- Lead, develop and maintain GMP innovative laboratories for Microbiological analytics and ensure procedural documents are in place to accurately lead Microbiological related processes and testing
- Ensure MBQC labs are every time ready for Health Authorities inspection (audit readiness) & Customer visits
- Responsible for the timely evaluation, development, validation and re-validation of Microbiological QC test procedures as well as evaluation, procurement, qualification, re-qualification, maintenance (service/cleaning), calibration and monitoring of equipment
- Ensure timely and compliant collection of all QC analytical samples and all required materials and reagents, including “reference and control” materials (reagents, test-kits, standards, etc.) are available
- Timely execution and evaluation of analytical testing (either internally or externally tested) to ensure business expectations are met
- Ensure testing results are documented according to GDP and in a way to preserve data integrity
- Consistent and timely investigation of OOE/OOS-results and laboratories deviations
- On demand, support and lead internal to QC/QM/LGN projects
**Your qualifications**:
- University Degree (Master or higher) in Microbiology, Biology or Life Science
- Many years of experience in highly regulated industry (GxP, Food, Medical Device)
- Proven experience as people manager in quality control
- Confirmed experience and knowledge in Microbiological QC methods, method validation and analytical issue management
- Knowledge in sampling of utilities, environmental monitoring samples and raw materials
- Able to lead by example, providing technical and personal support.
- Excellent time management skills, with the flexibility to handle changing priorities and multiple tasks at the same time
- Working proficiency in English and the ability to communicate in German is a required
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects an exciting company culture that stands for integrity, intensity, involvement, and innovation
Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Agency note
-
Manager Bio-/chemical Quality Control
vor 2 Monaten
Lengnau, Schweiz Thermo Fisher Scientific Vollzeit**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office The Quality Control management team is seeking a leader for the Bio-/Chemical Unit (BCQC) at Thermo Fisher, Lengnau site. The job holder is responsible for maintaining a brand-new laboratory for Biochemical and...
-
Manager Bio-/Chemical Quality Control
vor 3 Wochen
Lengnau, Schweiz Thermo Fisher Scientific VollzeitWork Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description The Quality Control management team is seeking a leader for the Bio-/Chemical Unit (BCQC) at Thermo Fisher, Lengnau site. The job holder is responsible for maintaining a brand-new laboratory for...
-
Manager Usp Labs, Lengnau
vor 5 Monaten
Lengnau, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is a global leader in serving science with annual sales of more than $40 billion. Our mission is to help our customers make the world healthier, cleaner and safer. We support our customers advance life science research, solve complex analytical challenges, increase efficiency in their laboratories, improve patient health through...
-
Manager Usp Labs, Lengnau
vor 6 Monaten
Lengnau, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is a global leader in serving science with annual sales of more than $40 billion. Our mission is to help our customers make the world healthier, cleaner and safer. We support our customers advance life science research, solve complex analytical challenges, increase efficiency in their laboratories, improve patient health through...
-
Senior Quality Assurance Specialist
vor 1 Monat
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitJob SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Thermo Fisher Scientific in Lengnau. The successful candidate will be responsible for ensuring the quality and sterility of our products, as well as implementing and maintaining our contamination control strategy.Key ResponsibilitiesProvide quality oversight of...
-
Senior Quality Assurance Manager
vor 3 Wochen
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitJob Summary:We are seeking a highly experienced Senior Quality Assurance Manager to lead our QA team at Thermo Fisher Scientific. The ideal candidate will have a Master's degree in a life science field and at least 6 years of experience in quality assurance and regulatory compliance.Main Responsibilities:Lead and manage a team of 5-6 QA professionals,...
-
Senior QA Sterility Assurance
vor 4 Monaten
Lengnau, Schweiz Thermo Fisher Scientific Vollzeit: Have quality oversight of all sterility assurance and microbial related-topics in Lengnau site. Responsible for setting up the overall microbial control concepts on the Lengnau site. Ensure the review and approval as a quality function for protocols, reports, procedures, and other relevant documents required for contamination control strategy,...
-
Scientist Bio-/chemical Quality Control
vor 5 Monaten
Lengnau, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. ist das weltweit führende Unternehmen im Dienste der Wissenschaft mit einem Jahresumsatz von rund 40 Milliarden US-Dollar. Unsere Mission ist es, unsere Kunden dabei zu unterstützen, die Welt gesünder, sauberer und sicherer zu machen. Wir unterstützen unsere Kunden, die biowissenschaftliche Forschung voranzutreiben, bei der...
-
Scientific Quality Assurance Specialist
vor 4 Wochen
Lengnau BE, Bern, Schweiz ThermoFisher VollzeitJob Description:Thermo Fisher Scientific is seeking a skilled Scientist Electronic Laboratory Systems Quality Control to join our world-class Quality Control team based at our PSG Large Molecule site in Lengnau. The successful candidate will be responsible for ensuring that processes, analytical equipment, and related applications align with health authority...
-
Manager, QA Systems
vor 3 Monaten
Lengnau, Schweiz Thermo Fisher Scientific Vollzeit**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards **Manager, QA Systems & Compliance**: Thermo Fisher Scientific Inc. Lengnau is seeking an exceptionally qualified individual with a strong track record and experience in managing QA Systems & Compliance to join our team...
-
Senior QA Sterility Assurance
vor 1 Monat
Lengnau, Schweiz Thermo Fisher Scientific VollzeitWork Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description Senior QA Sterility Assurance Thermo Fisher Scientific Inc., Lengnau is seeking a highly motivated and experienced individual to join our team as a Senior QA Sterility Assurance. This is an exceptional...
-
Scientist Ii, Quality Control Raw Material Release
vor 6 Monaten
Lengnau, Schweiz Thermo Fisher Scientific VollzeitWhen you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make...
-
Scientist Ii, Quality Control Raw Material Release
vor 6 Monaten
Lengnau, Schweiz Thermo Fisher Scientific VollzeitWhen you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make...
-
Quality Control Specialist
vor 2 Wochen
Lengnau BE, Bern, Schweiz ThermoFisher VollzeitKey Responsibilities for Electronic Laboratory Systems Quality Control Specialist at Thermo Fisher Scientific:Manage the lifecycle of QC systems and provide first & second-level support to meet customer and health authority expectations.Participate in the qualification of analytical equipment, including Computer System Validation (CSV).Deliver timely support...
-
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitJob DescriptionThis role is responsible for leading and managing a team of quality assurance professionals, ensuring compliance with cGMP regulations and international health authority guidelines. The ideal candidate will have a Master's degree in a life science field or equivalent experience, along with a strong understanding of operations and quality...
-
Senior Microbiologist Sterility Assurance
vor 2 Wochen
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitJob Summary:Thermo Fisher Scientific Inc. is seeking a Senior Microbiologist Sterility Assurance to oversee sterility assurance and microbial related-topics in Lengnau site.Responsibilities:Have quality oversight of all sterility assurance and microbial related-topics in Lengnau site.Responsible for setting up the overall microbial control concepts on the...
-
Manager, QA Systems
vor 4 Monaten
Lengnau, Schweiz Thermo Fisher Scientific Vollzeit: Lead and manage a team of 5-6 QA professionals, providing direction and support for their professional development. Provide oversight and supervision of the compliance activities within Lengnau site. Interact with varying levels of staff within the organization as well as with customers and auditors to determine and successfully implement compliance...
-
Sr Manager, Division Quality Systems and
vor 5 Monaten
Lengnau, Schweiz Thermo Fisher Scientific VollzeitAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Join our distributed team of more than 100,000 colleagues in bringing our Mission to life every single day to enable...
-
Laborant (M/w/d) Microbiological Quality Control
vor 3 Monaten
Lengnau, Schweiz Thermo Fisher Scientific Vollzeit**Work Schedule** Other **Environmental Conditions** Office Thermo Fisher Scientific Inc. ist der weltweit führende Partner für die Wissenschaft mit einem Umsatz von 40 Mrd. USD und mehr als 100.000 Mitarbeitern in 55 Ländern. Unsere Mission ist es, unsere Kunden in die Lage zu versetzen, die Welt gesünder, sauberer und sicherer zu machen. Sie sind...
-
Manager Manufacturing Operation
vor 5 Monaten
Lengnau, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, increasing productivity in their...
