QC Coordination Specialist
7 days ago
About Us
At AGC Biologics, we strive to be a collaborative, purpose-driven organization that values teamwork, personal development, and innovation. We are dedicated to improving patients' lives by bringing new biopharmaceuticals to market.
Job Description
In this role, you will play a central part in ensuring QC Chemistry delivers on its commitments. Your responsibilities will include:
Key Tasks:
Representing Our Team: You will represent our team in customer project teams, core project teams, and internal QC groups.
Leading Cross-Functional Teams: You will lead cross-functional QC analytical project teams to drive progress and meet milestones.
Coordinating Method Validations: You will oversee the coordination of method validations, transfers, and batch release schedules.
Writing and Reviewing Documentation: You will write, review, and approve GMP documentation, including CAPAs, deviations, CoAs, and change control cases.
Advising Management: You will advise management on QC-related matters and contribute to organizational optimization and process improvement.
Participating in Regulatory Inspections: You will participate in regulatory inspections (e.g., DMA, FDA) and customer audits.
Your Qualifications
The ideal candidate will have a mix of technical expertise, project coordination skills, and a proactive mindset. Key qualifications and skills include:
Education: MSc in Chemistry, Biochemistry, or a related field with 2–6 years of relevant experience; or PhD with 3 years of relevant experience.
Technical Expertise: Solid experience with analytical chemistry techniques (e.g., HPLC, CE, iCE).
Project Management: Ability to manage multiple projects, oversee milestones, and drive coordination across stakeholders.
GMP Knowledge: Experience working in cGMP settings under EU and US regulatory guidelines.
Communication Skills: Strong interpersonal skills to build relationships and effectively communicate with both internal and external stakeholders.
Fluency in English: Written and spoken. Interest in learning Danish is an advantage.
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