Quality Control Associate II
Our client a global Pharma company in Solothurn, is looking for a motivated Quality Control Associate.
General Information:
Industry: Pharmaceutical
Location: Solothurn
Start date: 01.04.2025
End Date: 31.12.2025
The Associate II Quality Control will be responsible for the ordering, management and distribution of QC related reagents and consumables through all QC laboratories on site inclusive WIP and Raw material areas. The Associate II needs to collaborate with the responsible persons of the related vendor managed inventory (VMI) system. It also includes the preparation of solutions like liquid chromatography buffers, TOC testing (solutions and consumables) or other analytical solutions. Furthermore, reference standards and qualified materials need to be ordered and managed for the quality control teams, whereby a close collaboration with the global reference QC group is mandatory. Associate II will be also responsible for washing and distribution of QC labware.
You will be responsible that all QC related non-analytical testing equipment like freezers are in a GMP-compliant status. The job duties include work order management, defrosting & cleaning activities.
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.
The Company operates with high-automated and integrated systems which also trigger GMP relevant alerts. The Associate II is responsible to assess and process those alerts via the quality review manager (QRM). You will work in a GMP compliant environment, where you will need to author, review and approve complex GMP documentation (Plans, protocols, procedures, specifications, CAPAs, deviations etc.).
What You'll Do
1. 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.
2. Aliquotation & sub-sampling of drug substance bags to QC samples.
3. 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.
4. 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.
5. Ordering, management and distribution of QC related reagents and consumables through all QC laboratories on site, as well as management of QC labware.
6. Authoring, reviewing and approving complex GMP documentation (Plans, protocols, procedures, specifications, CAPAs, deviations etc.).
Required Skills
7. Associate's Degree, technical degree (1-2 years), or Bachelor's Degree.
8. Prior experience in pharmaceutical or biotech manufacturing environments, preferably in GMP Quality Control.
9. Basic knowledge of Microbiology and Chemistry.
10. Skills in buffer and solution preparation are preferred.
11. Experience in aseptical working.
12. Strong organizational skills and ability to work autonomously.
13. Effective communication skills across all levels of management, peers, contractors, and external partners.
14. Proficiency in typical productivity software (Word, Excel, Outlook, etc.).
15. Preferably familiar with LabWare LIMS and Oracle systems.
16. Dual language proficiency preferred, with a preference for German and English (minimum level B1).
If this job interests you please do send us your CV today through the link in the advert. However, should you have any questions please contact Elaine Kanwar at +41 61 282 22 23