As a Quality Control Specialist, you will be responsible for managing 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.
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.
About the Role
* Preparation, movement, and shipping of QC test, stability & retain samples.
* 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.
* 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.
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.
We are looking for a highly skilled and detail-oriented individual to join our team as a Quality Control Associate.