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.
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
Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. 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 Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.