Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Join our team at Thermo Fisher Scientific as a Senior Scientist Bio-/Chemical Quality Control in Lengnau This is an outstanding chance to collaborate with a world-class group committed to making a meaningful impact in the field of bio-/chemical quality control.
Job Responsibilities
* Ensure timely completion of Bio-/Chemical Quality Control (BCQC) tasks.
* Take part in the transfer, development, and validation of analytical methods, including equipment qualification.
* Contribute actively to GMP Inspection Readiness, ensuring full compliance with relevant Quality Systems and Procedural documents.
* Manage QC operational readiness by leading all aspects of projects and coordinating daily tasks for assigned resources.
Processes and Methods Implementation
* Coordinate actions to establish processes and analytical methods for testing finished products, in-process controls, intermediates, raw materials, utility, and cleaning samples.
* Write and revise standard operating procedures (SOPs) and instructions.
* Review and approve methods, plans, protocols, and reports.
* Manage procurement, qualification, calibration, and maintenance of analytical and infrastructure equipment.
* Coordinate the development, transfer, and validation of analytical procedures according to timelines.
Project Leadership
* Represent BCQC in projects and workgroups, ensuring data-driven workload definitions.
* Lead the implementation of both local and global projects within the QC department, promoting collaboration and alignment with things we value.
* Drive the problem-solving process for any project-related issues.
QC Execution
* Document and deposit raw data, results, reports, and journals.
* Assist in resolving issues related to bio-/chemical analytics and ensure timely investigation of deviations.
* Mentor QC colleagues in GMP and Quality Control practices.
Requirements
* At least 2 years of experience working in a GMP-regulated industry.
* 3-5 years of experience working in a laboratory setting.
* Demonstrated experience in (bio) chemical QC methods, method validation, and handling analytical issues.
* Demonstrated background in coordinating projects and tasks.
* 5 years of background in chemical or biochemical laboratories, including experience in a regulated GMP setting.
We are seeking ambitious individuals with outstanding abilities to join our team. If you're ready to contribute to a collaborative and innovative environment, apply now and make a difference with Thermo Fisher Scientific