Join Us in Bringing Hope to Life
Our purpose is to bring hope to life by enabling life‑changing therapies for patients around the globe, creating a healthier and happier tomorrow. To advance this purpose, we rely on team members who value excellence, collaboration, and meaningful work. If this resonates with you, we invite you to explore the role further and apply.
Job Summary
We are seeking a Quality Assurance Scientist to provide day‑to‑day QA support, review, and approval of GMP documentation and activities. This role supports SOPs, master batch records, and methods, and participates in troubleshooting quality issues across Manufacturing, QC, Engineering (EOS), and Warehousing.
The QA team plays a hands‑on role in ensuring compliance, supporting investigations and CAPAs, and partnering cross‑functionally to maintain GMP standards across site operations.
About the Quality Assurance Team
You will join a Quality Assurance team responsible for providing real‑time quality support and oversight across manufacturing and support functions. The team partners closely with Manufacturing, QC, Engineering, and Warehouse teams to ensure compliance, issue resolution, and continuous improvement in a regulated GMP environment.
Key Responsibilities
Provide daily quality support and oversight for designated functional areas, including Manufacturing, Engineering (EOS), QC, and Warehouse operations.
Review and approve GMP documentation such as SOPs, master batch records, and methods for accuracy and compliance.
Review executed batch records for completeness, accuracy, and GMP compliance; partner with stakeholders to resolve documentation issues.
Facilitate deviation investigations, CAPAs, and change records for simple to moderate issues.
Identify and escalate potential compliance risks and quality concerns.
Participate in troubleshooting activities related to QC, Manufacturing, and preventive maintenance.
Provide technical guidance and quality leadership within assigned work areas.
Coordinate with cross‑functional teams to meet business needs and output requirements.
Support prioritization and execution of project goals within the work area.
Coach team members on task execution and skill proficiency with manager guidance.
Skills & Competencies
Demonstrated technical proficiency in quality systems and GMP operations.
Ability to communicate clearly within the team and increasingly across functional groups.
Works closely with management and applies guidance to deliver effective results.
Proactively identifies needs and potential issues based on prior experience.
Begins to support the development and guidance of junior team members.
Qualifications & Experience
Required:
Bachelor’s degree with 5+ years of relevant experience, or
Master’s degree with 2+ years of relevant experience, or
PhD (or equivalent) with 0–2+ years of experience, including postdoctoral experience where applicable.
Equivalent education and experience may be considered.
Formalities
Location: Bothell, WA
Schedule: Full‑time, Monday through Friday
Compensation: $83,920 - $115,390
Who We Are
AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in the United States. From our headquarters in Bothell, Washington, we develop and manufacture life‑changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
We are a collaborative, inclusive, and equal‑opportunity organization where team members are valued for their expertise, teamwork, and ingenuity.
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What We Do
AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics (using mammalian and microbial systems), mRNA, pDNA, viral vector and cell therapy products, from pre-clinical to commercial production, including our proprietary CHEF1TM Expression System for efficient protein production with CHO cells. Our company DNA drives us to provide innovative solutions to partner with our customers in helping them reach their goals and accelerate their projects at our cGMP-compliant facilities in the US, Europe and Japan, as well as to facilitate approval and manage spending during the product lifecycle. We forge exceptionally strong partnerships with our customers and we never lose sight of our commitment to deliver reliable and compliant drug substance. Visit www.agcbio.com to learn more.
