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Senior Scientist, Quality Assurance Specialist
2 months ago
About the Role:
We are seeking a highly motivated and experienced QA Scientist to join our team at AGC Biologics. As a QA Scientist, you will play a vital role in ensuring the quality and compliance of our manufacturing processes and facilities.
Key Responsibilities:
As a QA Scientist, your primary responsibilities will include:
- Reviewing and approving technical documents, including change controls, deviations, CAPAs, risk assessments, SOPs, validation plans, and qualification protocols and reports.
- Conducting GEMBA walks in GMP areas to ensure compliance with Good Manufacturing Practice (GMP) standards.
- Communicating with internal and external stakeholders to resolve and clarify any points of issue.
- Participating in the development and implementation of quality standards for qualification, calibration, EM, cleaning, and other facility and engineering activities.
Requirements:
To be successful in this role, you will need:
- A science-based degree.
- Experience working in or directly supporting manufacturing operations in a drug substance/product manufacturing site.
- Prior biopharmaceutical experience is desirable.
- A thorough understanding of Good Manufacturing Practice (GMP) principles and guidelines.
- Experience with the qualification of GMP facilities, equipment, and computerized systems.
- Knowledge of Data Integrity principles.
- Strong decision-making skills and a proactive attitude.
- Excellent written and verbal communication skills.
- Ability to work efficiently in a fast-paced, matrix environment.
- Ability to meet deadlines and effectively manage multiple tasks.
- Flexibility to adapt to changing business needs and priorities.
About AGC Biologics:
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. We deliver a deep expertise, dynamic solutions, and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies.
What We Offer:
We offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced QA Scientist looking for a new challenge, we encourage you to apply.
