Quality Control Associate I

AGC Biologics•Bothell, WA

12h•Onsite

About The Position

AGC Biologics is seeking a Quality Control Associate I to support Quality Control Microbiology operations at our Seattle site. This role performs routine microbiological testing, environmental monitoring, and sample coordination activities to ensure product quality and regulatory compliance. The QC Associate I works in a hands‑on laboratory environment and partners closely with QC team members to deliver accurate, timely results that support manufacturing operations and patient needs. About the Quality Control Microbiology Team You’ll join the Quality Control Microbiology team, responsible for environmental monitoring and microbiological testing in support of manufacturing operations and product release. The team operates in a regulated, fast‑paced laboratory environment and partners closely with Manufacturing, Quality, and Technical Operations to ensure data integrity, regulatory compliance, and patient safety. Collaboration, attention to detail, and continuous learning are central to how the team works.

Requirements

Understanding of GxP principles and laboratory compliance expectations.
Ability to gown and work in classified cleanroom environments, including ISO 5 and ISO 6 areas.
Comfortable performing work in controlled environments requiring standing, bending, reaching, twisting, squatting, and movement while gowned.
Working knowledge of basic microbiology techniques and aseptic handling practices.
Proficiency with Microsoft Office applications.
Strong attention to detail and ability to follow written procedures accurately.
Bachelor’s degree in Microbiology or a related scientific field, or A minimum of 2+ years of relevant Quality Control or microbiology laboratory experience.

Nice To Haves

Familiarity with cGMP and pharmaceutical regulatory requirements
experience with Smartsheet preferred.

Responsibilities

Receive, route, store, and track QC samples using LIMS (LabWare).
Perform routine maintenance and monitoring of QC equipment, including temperature‑controlled units, balances, pH meters, and water baths.
Receive and log external materials submitted to QC; prepare outgoing sample shipments for clients and vendors.
Perform environmental monitoring activities, including non‑viable air, viable air, surface, and utility sampling.
Execute laboratory testing such as bioburden, endotoxin, microbial identification, total organic carbon (TOC), appearance, pH, and conductivity testing.
Generate, review, enter, and trend laboratory data in accordance with GMP procedures.
Communicate effectively with supervisors and team members to ensure work is completed accurately and on time.
Support projects, initiatives, and team deliverables as assigned.
Actively seek opportunities to learn, develop technical skills, and improve laboratory practices.