QA Microbial Scientist Role at AGC Biologics, Apply Now!
Are you passionate about quality assurance in biopharmaceutical manufacturing? AGC Biologics is seeking a QA Microbial Scientist to ensure GMP compliance and oversee critical manufacturing processes. Join a dynamic QA Operations team committed to quality, innovation, and international collaboration in microbial drug substance production.
Company Overview: AGC Biologics is renowned for its excellence in providing high-quality manufacturing services for drug substances and cell banks. The Quality Assurance Operations department plays a crucial role in ensuring compliance with industry standards and customer satisfaction. With a focus on professionalism and innovation, AGC Biologics values open communication and collaboration to uphold the highest quality standards.
Role & Responsibilities for QA Microbial Scientist Role:
The QA Scientist provides customer service, with the highest integrity, focused on quality and compliance in partnership with AGC Biologics.
Your daily responsibilities include ensuring resolution of significant quality issues with the client through coordination and collaboration of internal functional resources to identify, propose and carry out an efficient plan to settle the issue, while protecting product quality and patient’s safety. Your will be responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to:
- Batch production records (BPR).
- Change controls
- Deviations
- CAPAs
- DS specifications
- Master Production Records
- Risk Assessments
In addition, responsibilities include for QA:
- Supporting the generation of new, as well as improvement of, existing department SOPs
- Supporting delivery of AGC projects
- Working with management to resolve project issues and resource constraints within the team
- Supporting client audits as necessary as QA.
- Assisting with negotiation terms of Quality agreements with the client as required
- Liaising with the internal and external stakeholders to resolve and clarify any point of issue
- Assisting with the generation of APQR (Annual Product Quality Review)
Your Profile:
It is of utmost importance to have a self-motivating personality with a pragmatic attitude and approach to the daily work – without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our customers a positive experience.
The ideal candidate would bring several of the following experiences and characteristics:
- You have 1-2 years of experience with Quality Assurance or >3 years relevant GMP experience as QA.
- A science-based Master’s degree or equivalent.
- Substantial experience working in or directly supporting manufacturing within a drug substance/product manufacturing site.
- Previous biopharma experience is preferred.
- Strong working knowledge of the principles and guidelines for GMP.
- Strong decision making and ‘can do’ attitude as QA.
- Excellent written and verbal communication skills to internal and external stakeholders.
- Ability to work in a fast paced, matrix environment essential.
- Capable of working to deadlines and prioritizing multiple tasks.
- Flexibility to meet the changing needs and priorities of the business.
AGC has international customers, and our company language is English. It is therefore a required ability that communication in both written and spoken English is fluent.
Keywords: Scientist QA, Microbial, Job, AGC Biologics, Quality Assurance, GMP, Drug Manufacturing, Biopharma
