Compliance Specialist II
Thermo Fisher ScientificSalary not specified
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Biopharmaceutical, CDMOIndustries
Requirements
- Degree in a scientific field (Laurea in ambito scientifico)
- Knowledge of GMP
- Good knowledge of English language and Microsoft Office package
Responsibilities
- Provide support in issuing/managing Engineering & Facilities documentation
- Coordinate training activities for Engineering & Facilities personnel
- Manage/coordinate Engineering & Facilities activities related to changes, deviations, and CAPA, and serve as the reference person for Quality on these topics
- Participate in regulatory inspections and customer audits
- Integrate/support other Engineering & Facilities areas as requested by the Engineering & Facilities Director, consistent with one's training plan
Skills
GMP
Engineering Documentation
Training Coordination
Change Management
Deviations
CAPA
Regulatory Inspections
Quality Compliance
Microsoft Office
English
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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