Scientist, QA Manufacturing Support Specialist
1 month ago
Job Summary: We are seeking a highly skilled Scientist, QA Manufacturing Support to join our team at AGC Biologics. As a key member of our Quality Assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing operations.
Key Responsibilities:
- Provide quality support to manufacturing operations, ensuring compliance with procedures and GMP requirements.
- Review and approve manufacturing records and logbooks in real-time.
- Collaborate with manufacturing teams to resolve quality-related issues.
- Conduct batch record reviews and approvals as part of the batch release process.
- Participate in Gemba walks and conduct site systems audits to ensure compliance.
- Review and approve validation and qualification documentation.
- Support manufacturing teams in driving improvements in GMP compliance.
- Perform quality reviews and approvals of deviations, change controls, and CAPAs.
Requirements:
- Bachelor's and/or Master's degree in Natural Sciences.
- Alternatively, certified laboratory technician with a degree in laboratory science, biotechnology, or medical laboratory technology, with 3-5 years of experience in a GMP environment.
- Experience with BPR/MPR review is a plus.
- Previous biopharma experience is preferred but not required.
- Strong working knowledge of GMP principles and guidelines.
- Excellent written and verbal communication skills.
- Ability to work in a fast-paced, matrix environment.
About AGC Biologics:
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA, messenger RNA, viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan.
What We Offer:
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. We are an equal opportunity employer and welcome applications from diverse candidates.
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