Quality Assurance Specialist
2 months ago
Are you a motivated and experienced Quality Assurance professional looking for a new challenge? Do you have a strong background in quality management and a passion for ensuring compliance with regulatory requirements?
We are seeking a highly skilled Quality Assurance Specialist to join our team at AGC Biologics. As a Quality Assurance Specialist, you will be responsible for supporting the commercial and late stage clinical phase GMP manufacturing of biological intermediates, APIs, and Cell Banks.
Your key responsibilities will include:
- Collaborating with internal stakeholders to ensure effective quality management practices
- Reviewing and approving material specifications and cGMP documentation
- Providing guidance on quality-related activities to staff members
- Ensuring compliance with regulatory requirements, including EU GMP, 21 CFR, and ICH guidelines
To succeed in this role, you will need:
- 3+ years of experience in Quality Assurance and/or material management
- A relevant academic background in pharmacy, biotechnology, biology, chemistry, or similar
- Excellent communication skills, both written and verbal, in English
In return, you can expect a competitive salary of approximately $95,000 per year, based on industry standards and your level of experience. You will also enjoy a dynamic and challenging work environment, opportunities for growth and development, and a chance to work with a talented team of professionals who share your passion for quality and compliance.
About AGC Biologics: We are a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy, and the USA. Our team is dedicated to providing high-quality services to our clients, and we take pride in our ability to adapt to their unique needs and requirements.
If you are a motivated and experienced Quality Assurance professional looking for a new challenge, we encourage you to apply for this exciting opportunity. Please submit your application, including your resume and cover letter, via our career site.
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