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Quality control associate

Luterbach
Randstad Switzerland
EUR 30’000 - EUR 80’000 pro Jahr
Inserat online seit: 14 Juni
Beschreibung

For our client, a leading global biotechnology company, we are looking for a Quality Control Associate (Sample Management & Logistics).

General Information:

* Start date: 01.07.2025
* End Date: 31.12.2025, with the possibility of extension
* Workplace: Luterbach, Solothurn
* Workload: 100%
* Working hours: Standard

About the job:

As an Associate in Quality Control (QC) Sample Management & Logistics at our client’s site, you will manage QC test, stability, and retain samples, ensuring GMP-compliant documentation and chain of custody. This includes handling sample movement, shipping, and coordination with departments like trade compliance and warehouse.

You will also manage Manufacturing Science (MS) samples via TD LIMS, perform aliquoting and sub-sampling to maintain sample integrity, and handle ordering, distribution, and preparation of QC reagents, consumables, and reference materials in collaboration with global teams.

Additionally, you will oversee GMP-compliant maintenance of QC non-analytical equipment, process system alerts through the Quality Review Manager, and author, review, and approve GMP documentation such as protocols, procedures, CAPAs, and deviations within an automated and integrated environment.

Your Profile:

The “ideal candidate” has introductory experience in the pharmaceutical or biotech manufacturing sector, preferably with prior engagement in a GMP Quality Control role and familiarity in procuring quality-controlled goods. Additionally, you possess fundamental knowledge of Microbiology and Chemistry, along with experience in aseptic work environments.

Tasks & Responsibilities:

* Management (preparation, moving, shipping) of QC test, stability & retain samples including trade and GMP compliant documentation including support of day to day operations within the site.
* Aliquotation & sub-sampling of drug substance bags to QC samples.
* Sample Shipment: Organize and coordinate sample shipment for raw material tailgate samples, material science tailgates, manufacturing science samples, analytical development and technical development samples as well as shipment to partner organizations and CLOs.
* Support day to day operations within the Central and WIP laboratories, including management of work orders for QC related non-analytical testing equipment like freezers.
* Ordering, management and distribution of QC related reagents and consumables through all QC laboratories on site, as well as management of QC labware.
* Authoring, reviewing and approving complex GMP documentation (Plans, protocols, procedures, specifications, CAPAs, deviations etc.).

Requirements:

* Associate’s Degree, technical degree (1-2 years), or Bachelor’s Degree.
* Prior experience in pharmaceutical or biotech manufacturing environments, preferably in GMP Quality Control.
* Basic knowledge of Microbiology and Chemistry.
* Skills in buffer and solution preparation are preferred.
* Experience in aseptic techniques.
* Strong organizational skills and ability to work autonomously.
* Effective communication skills across all levels of management, peers, contractors, and external partners.
* Proficiency in typical productivity software (Word, Excel, Outlook, etc.).
* Preferably familiar with LabWare LIMS and Oracle systems.
* English (minimum level B1) and German is a plus.

Sounds interesting? Apply now – we’re looking forward to receiving your applications!

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