Job Description
We are seeking an Associate II Quality Control Sample Management & Logistics professional to join our team at the Solothurn facility.
About the Job
This role involves managing quality control test, stability, and retain samples, ensuring compliance with Good Manufacturing Practices (GMP) and legal requirements. Responsibilities include:
* Sample movement, documentation, and shipping using systems like Laboratory Information Management System (LIMS) and Oracle.
* Management of quality control reagents, consumables, and reference standards.
* Collaboration with vendors and global quality control teams.
* Evaluation and implementation of GMP-compliant solutions for quality control laboratory equipment and non-analytical testing devices.
Tasks & Responsibilities
The successful candidate will be responsible for:
* Preparing, moving, and shipping quality control test, stability, and retain samples, including trade and GMP-compliant documentation.
* Aliquoting and sub-sampling of drug substance bags for quality control purposes.
* Organizing and coordinating sample shipments for various stakeholders.
* Supporting day-to-day operations within the central and work-in-progress laboratories.
* Ordering, managing, and distributing quality control-related reagents and consumables.
* Authoring, reviewing, and approving complex GMP documentation.
Requirements
To be considered for this position, candidates should possess:
* Introductory experience in the pharmaceutical or biotechnology manufacturing sector.
* Prior engagement in a GMP Quality Control role and familiarity with procuring quality-controlled goods.
* Fundamental knowledge of microbiology and chemistry.
* Experience working in aseptic environments.
Preferred Skills
The ideal candidate will also have:
* Dual language proficiency, preferably German and English.
* An associate's degree, technical degree, or bachelor's degree.
* Prior experience in pharmaceutical or biotech manufacturing environments.
* Basic knowledge of microbiology and chemistry.
* Preferred skills in buffer and solution preparation.
* First-hand experience in aseptical working.
* Strong organizational and communication skills.
* Proficiency in typical productivity software.
Language: en