Quality Assurance Scientist I

AGC Biologics•Bothell, WA

1d•Onsite

About The Position

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. 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. 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.

Requirements

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.
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.

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.