The selected candidate will be responsible for the following task area:
* 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.).
To be considered for this position, the ideal candidate must have:
* 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 aseptical working.
* 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 proficiency is a must have.
Excellent project to join a well-known and prestigious pharmaceutical company.