5 beste Stellen als medical device in biel bienne be – aktuell auf Personalsuche

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Scientist Microbiological Quality Control

Thermo Fisher Scientific -
Lengnau, BE

Jetzt bewerben

Details zur Stelle

100% | Pensum: 90-100%

Qualifikationen

Doktorat
Qualitätskontrolle
Organisationstalent
Reinraum
Qualitätssysteme
Kommunikationsfähigkeit

Vollständige Stellenbeschreibung

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Description:
Join our team at Thermo Fisher Scientific as a Lead QC Technician, where you'll help make the world healthier, cleaner and safer. In this important role, you'll ensure quality standards are met through testing and inspection of products in a cGMP environment. You'll coordinate quality control activities, lead a team of QC technicians, and collaborate with cross-functional teams to maintain the highest quality standards. You'll perform analytical testing, document results, and support continuous improvement initiatives while mentoring team members.

Responsibilities :

Responsible for the organization of daily operations in the Microbiological QC (MBQC) laboratory and to maintain the laboratory operational (incl. maintenance of equipment).
Responsible for the creation and revision of guidance documents such as SOPs/Wls and other related documents.
System Matter Expert (SME) for Bioburden, Growth Promotion, Micro Identifications and Endotoxin testing method and related quality events.
Participates in the transfer, development and verification/validation of microbiological methods including qualification of equipment needed for analysis.
Testing of final and intermediate products, in process samples, samples from cleaning validation, utilities and environmental monitoring samples as back up.
Supports the GMP Inspection Readiness of QC to ensure the fully compliance of relevant Quality System and Procedural documents.
Supports of the QC teams (MBQC and Service and Support) in the ordering of material, logistic of samples and inventory management of the QC labs.
Acts as Biosafety officer at the Thermo Fisher Scientific Lengnau site in accordance with the Swiss law (SAMV, ESV).

Requirements:

Minimum 4 years of experience in quality control within a regulated environment (pharmaceutical/medical device preferred)
Preferred Fields of Study: Chemistry, Biology, or related scientific field
Demonstrated 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
Proven 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 as needed
Problem-solving skills and ability to troubleshoot technical issues
Experience writing and reviewing SOPs and technical documentation

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