Biologics Manufacturing Specialist
5 days ago
At AGC Biologics, our purpose is to bring hope to life by enabling life-changing therapies for patients worldwide. We create a healthier and happier tomorrow by working side by side with our customers to improve patients' lives through new biopharmaceuticals.
We are seeking an experienced QA scientist to assist with Quality Assurance of Material Management. This critical role will join a diverse team of highly qualified colleagues, many with several years of experience within quality assurance.
This QA team supports Supply Chain Management and QC in areas such as deviations, CAPA, change management, complaints, GMP documentation, and internal/external audits and regulatory inspections. The department has open communication, focusing on professionalism, and we prioritize the continuous improvement of our quality system.
The successful candidate will be involved in various daily operational tasks in a dynamic and challenging environment. Main responsibilities include supporting Supply chain, Process Transfer, and QC for late stage and commercial products, which includes:
- Collaboration with internal stakeholders
- Change control, deviation handling, and CAPAs
- Review and approval of material specifications
- Release of raw materials and disposables
We foster close cooperation with other departments to ensure all quality-related activities are performed effectively and in compliance with cGMP.
Your ProfileYou have 3+ years of experience with Quality Assurance and/or material management. A relevant academic background within pharmacy, biotechnology, biology, chemistry, or similar is required.
You possess experience in the following areas:
- Proven experience from QA and/or Material Management
- 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 and business understanding
- Deviation handling including root cause investigations
- Review and evaluation of cGMP documentation
A self-motivating personality with a pragmatic attitude and approach to daily work is essential. You must be able to find solutions, deliver on promises, and provide our customers with a positive experience. English language proficiency is required for both written and spoken communication.
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