Quality Control Associate I at AGC Biologics

Bothell, Washington, United States

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Not SpecifiedCompensation

Entry Level & New Grad, Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceuticals, BiotechnologyIndustries

Requirements

BS/BA degree in Microbiology or a related field, or at least 2+ years of relevant QC experience
Familiarity with cGMP and regulatory requirements for pharmaceuticals (preferred)
Understanding of GxP standards
Ability to gown into a classified cleanroom environment, including aseptic spaces of ISO 5 and 6 classification
Comfortable working in controlled environments — standing, bending, reaching, twisting, squatting, and moving while gowned
Skilled in basic microbiology techniques and aseptic handling
Proficient with Microsoft Office and Smartsheet

Responsibilities

Receive, route, and store QC samples using LIMS Labware software
Perform routine QC equipment maintenance (temperature-controlled units, balances, pH meters, water baths, etc.)
Receive and log external materials sent to QC, and help prepare sample shipments for clients and vendors
Conduct facility monitoring of non-viable air, viable air, surfaces, and utilities
Generate, enter, and analyze data
Perform lab-based testing, including bioburden, endotoxin, microbial identification, total organic carbon, appearance, pH, and conductivity
Communicate effectively with managers and teammates to ensure work is completed on time
Seek opportunities to continue learning and improving your skills
Support projects, initiatives, and team goals by delivering on assigned tasks

Skills

LIMS Labware

cGMP

GxP

environmental monitoring

bioburden testing

endotoxin testing

microbial identification

total organic carbon

pH testing

conductivity testing

cleanroom gowning

AGC Biologics

Contract development and manufacturing for biopharmaceuticals

About AGC Biologics

AGC Biologics specializes in the development and manufacturing of therapeutic proteins, plasmid DNA, viral vectors, and genetically engineered cells for the biopharmaceutical industry. The company provides end-to-end solutions, assisting clients from the initial development stages to full-scale production. Their services are particularly focused on fast-tracking projects for orphan drugs and rare diseases, which often require quicker timelines. AGC Biologics operates a network of advanced facilities across the U.S., Europe, and Asia, all adhering to strict quality regulations known as current Good Manufacturing Practices (cGMP). What sets AGC Biologics apart from competitors is its commitment to continuous innovation and its recent expansion to enhance capabilities in cell and gene therapy. The company's goal is to support biopharmaceutical companies in bringing new treatments to market efficiently and effectively.

Bothell, WashingtonHeadquarters

2001Year Founded

$613MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Risks

Restructuring and layoffs in Colorado indicate potential financial instability.

Leadership changes may disrupt ongoing projects and affect client trust.

Significant investment in Japan could strain financial resources and divert focus.

Differentiation

AGC Biologics specializes in therapeutic proteins, plasmid DNA, and viral vectors.

The company offers fast-track project capabilities for orphan drugs and rare diseases.

AGC Biologics operates globally with facilities in the U.S., Europe, and Asia.

Upsides

Increased demand for plasmid DNA boosts AGC's gene therapy and vaccine services.

Partnership with BioConnection enhances biodrug development capabilities, attracting more clients.

Expansion in Yokohama aligns with growing mRNA and cell therapy demand.

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