Posted 8 days ago
QC Analytical Scientist
ReykjavikRemoteFull-time
AI Summary
Performs routine and non-routine analytical testing on pharmaceutical products using techniques such as LC and CE, supports manufacturing operations, and contributes to quality documentation, investigations, and change control within a GMP environment.
About this role
We are looking for a Scientist in Quality Control Product Testing team at Alvotech. The position plays a vital role by participating in the quality control and release of products manufactured at Alvotech. We are looking for an individual that has a positive attitude, embraces challenges, is flexible and adaptive, and shares our values of team spirit and team efforts.
Scope and responsibility:
- Performs routine analytical testing with advanced analytical techniques such as LC (APAC, SEC, CEX, N-glycan, Peptide mapping) and CE (CE-SDS, CIEF) as well as compendial methods support manufacturing operations.
- Participate in the creation, review and maintenance of quality documents within Alvotech.
- Contributes to other documentation reviews and/or updates within the Quality management system.
- Support the investigations for quality issues such as Invalid assay, OOS/OOT/OOE results.
- Support in change control, CAPAs, Document change controls.
- Performs both routine tasks within procedures, processes and non-routine tasks such as support Invalid assays, change controls, document updates and CAPAs.
- Performing routine cleaning, verification, stock checks, and upkeep of laboratory and equipment
- Performing activities required to support testing, e.g., buffer preparation
Job requirements:
- Bachelor’s or master’s Degree in a relevant scientific discipline and at least 1-5 years of relevant experience in the pharmaceutical or biopharmaceutical sector.
- Proficient in using a PC and common Microsoft packages such as Word and Excel.
- Understanding and review of electronic data from instrument software.
- Knowledge of Good Manufacturing Practices (GMP) and documentation Rules is an asset.
What we offer:
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration, and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Company social events and milestone celebrations.
- Excellent in-house canteen and coffee house.
- Exercise and well-being support for full-time employees.
- On-site shower facility.
- Transportation grant towards eco-friendly modes of travel for full-time employees.
- Internet at home for full-time employees.
Skills
Buffer PreparationCAPACE (CE-SDS, CIEF)Change ControlCompendial MethodsElectronic Data From Instrument SoftwareExcelGMPLaboratory Equipment MaintenanceLC (APAC, SEC, CEX, N-glycan, Peptide Mapping)Microsoft WordOOS/OOT/OOE Investigation
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