Quality Assurance Specialist
3 days ago
About AGC Biologics
AGC Biologics is a global Contract Development Manufacturing Organization (CDMO) providing comprehensive biologics manufacturing services. Our team tailors each client's needs for turnkey manufacturing or sophisticated analytical, formulation, and stability services.
We have facilities in Europe, Japan, Italy, and the USA, enabling us to serve clients worldwide. Our mission is to work side by side with customers to improve patients' lives by bringing new biopharmaceuticals to market.
Our purpose is to bring hope to life through enabling life-changing therapies globally, creating a healthier and happier tomorrow.
Job DescriptionAs a Quality Assurance Scientist, you will be involved in daily operational tasks in a dynamic environment.
Main responsibilities include supporting Supply Chain, Process Transfer, and QC for late-stage and commercial products:
- Closing collaborations with internal stakeholders
- Change control, deviation handling, and CAPAs
- Reviewing and approving material specifications
- Releasing raw materials and disposables
Collaboration with other departments ensures effective quality-related activities are carried out according to cGMP standards.
Required Skills and QualificationsYou have 3+ years of experience in Quality Assurance and/or material management.
A relevant academic background in pharmacy, biotechnology, biology, chemistry, or similar is required.
Proven experience in QA and/or material management, as well as requirements for commercial and/or late-state clinical phase GMP manufacturing of biological intermediates, APIs, and Cell Banks.
QA oversight and guidance of staff, experience with contract manufacturing, business understanding, deviation handling including root cause investigations, and review and evaluation of cGMP documentation.
A self-motivating personality with a pragmatic attitude and approach to daily work is crucial without compromising quality.
The ability to find solutions, deliver on promises, and provide a positive customer experience is essential.
Fluent written and spoken English communication is required due to international customers and company language.
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