Quality Assurance Scientist with Expertise in GMP Facilities
1 month ago
AGC Inc is seeking a Quality Assurance Scientist to join our team.
About the RoleThis position involves overseeing the quality assurance review and approval of technical documents, conducting GEMBA walks, and communicating with internal and external stakeholders.
Responsibilities- Review and approve technical documents, including change controls, deviations, CAPAs, risk assessments, SOPs, validation plans, requirements specifications, qualification protocols, and reports.
- Conduct regular GEMBA walks in GMP areas to ensure compliance with current Good Manufacturing Practice (GMP) standards.
- Communicate effectively with internal and external stakeholders to resolve issues and clarify points of concern.
- 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.
AGC Inc offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.
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