Senior Quality Assurance Specialist
2 weeks ago
We are seeking a highly motivated and detail-oriented Quality Assurance (QA) Scientist to join our team at AGC Biologics. As a QA Scientist, you will play a crucial role in ensuring the quality of our products and processes, adhering to Good Manufacturing Practice (GMP) standards.
Key Responsibilities- Oversee the quality assurance review and approval of technical documents, including change controls, deviations, CAPAs, risk assessments, SOPs, validation plans, requirements specifications, qualification protocols, and reports.
- Conduct GEMBA walks in GMP areas to ensure compliance with company policies and procedures.
- Communicate effectively with internal and external stakeholders to resolve and clarify any issues.
- Participate in setting standards for qualification, calibration, EM, cleaning, and other facility and engineering activities.
- A science-based degree.
- Experience working in or directly supporting manufacturing operations in a drug substance/product manufacturing site.
- Prior biopharmaceutical experience is desirable.
- Thorough understanding of 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.
The Quality Assurance department at AGC Biologics is a multidisciplinary team of over 80 colleagues, primarily responsible for Manufacturing, Raw Materials, Quality Control, and Facilities and Equipment. Our main objective is to ensure that our production facilities and laboratories comply with current GMP standards at all times.
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