quality control associate ii.

As Associate II Quality Control (QC) Sample Management & Logistics at Solothurn facility, you will manage QC test, stability, and retain samples, ensuring compliance with GMP and legal requirements. This includes sample movement, documentation, and shipping, using systems like LIMS and Oracle. You will also manage QC reagents, consumables, and reference standards, and collaborate with vendors and global QC teams. Additionally, you will ensure GMP compliance for QC lab equipment and non-analytical testing devices, as well as handle quality alerts and GMP documentation.


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.).

Who You Are:

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.


Required Skills:

• Dual Language preferred with a preferences for German and English. For English min. B1 is required.
• 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.
• Preferred skills in buffer and solution preparation.
• First experience in aseptical working.
• Strong organization 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.).
• Optimally have know-how with LabWare LIMS and Oracle system.

Apply Now!

If this sounds like the right opportunity for you, we look forward to receiving your application!