Quality Control Associate II
Gefunden in: beBee jobs CH - vor 1 Woche
Job Summary
The main responsibilities for the Quality Control Associate II will include sample management related activities at a manufacturing facility in Solothurn, Switzerland.
The Quality Control Associate II will be responsible for the management of QC test, stability & retain samples including GMP compliant documentation. The management means: The moving and shipping from site locations to internal and external locations with the main goal to ensure the chain of custody and according to standard work operations. Therefore, the Associate II will also need to work with a laboratory information management system (LIMS), as well with enterprise resource planning systems like Oracle. The work duties include the preparation of sample shipment documents in collaboration with trade compliance and warehouse department to ensure to be fully compliant according GMP but also legal requirements.
Tasks & ResponsibilitiesManagement (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.)
Must haves:Associate's Degree, technical degree (1-2 years) or Bachelor's DegreeFirst experience in pharmaceutical or biotech manufacturing environment. Optimally prior experience within a GMP Quality Control function and experience with purchasing quality controlled goods. Preferred skills in buffer and solution preparation.First experience in aseptical working.Strong organization skills and ability to work autonomously.Good ability to communicate with all levels of management, peers, contractors and external partners effectively.Good understanding of the basics of Microbiology and Chemistry.Optimally comfortable using LabWare LIMS and Oracle system.Dual Language preferred with a preferences for German (fleuncy) and English (min. B1)..
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