Senior Scientist, Quality Assurance Professional
1 month ago
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe.
We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in various locations.
Your Role: QA ScientistAs a QA Scientist, you will be a vital member of our multidisciplinary team. Your primary responsibilities will include overseeing the Quality Assurance review and approval of all technical documents, conducting GEMBA walks in GMP areas, communicating with internal and external stakeholders, and setting standards for qualification, calibration, and other facility and engineering activities.
Key Responsibilities:
- Review and approve quality documentation, including change controls, deviations, CAPAs, risk assessments, SOPs, validation plans, and qualification protocols and reports.
- Conduct GEMBA walks in GMP areas to ensure compliance with current Good Manufacturing Practice (GMP) standards.
- Communicate with internal and external stakeholders to resolve and clarify any points of issue.
- Participate in setting standards for qualification, calibration, and other facility and engineering activities.
We are looking for a highly motivated and self-motivated individual with a science-based degree and experience working in or directly supporting manufacturing operations in a drug substance/product manufacturing site. Prior biopharmaceutical experience is desirable, as well as a thorough understanding of Good Manufacturing Practice (GMP) principles and guidelines.
The ideal candidate should possess excellent written and verbal communication skills, strong decision-making skills, and a proactive attitude. Ability to work efficiently in a fast-paced, matrix environment and meet deadlines effectively is also essential.
What We OfferWe offer a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. As an equal opportunity employer, we welcome applications from diverse candidates who share our commitment to quality, innovation, and teamwork.
Estimated Salary: $85,000 - $110,000 per annum, depending on location and experience.
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