Manager of Quality Assurance and Regulatory Affairs Jobs in Washington
A Manager of Quality Assurance and Regulatory Affairs in the biotechnology industry is responsible for ensuring that all products and services meet required standards and regulations. They ensure compliance with local, national, and international regulatory requirements, oversee quality control processes, and manage audits and inspections. This role also involves creating and implementing policies and procedures to enhance product quality, efficiency, and safety. They also play a crucial role in the product development process, advising on regulatory requirements and ensuring that compliance is maintained throughout the lifecycle of a product.
Skills required for this role include excellent attention to detail, strong organizational and leadership skills, and in-depth knowledge of regulatory standards and quality control methods. In addition, they should have excellent problem-solving skills, the ability to work under pressure, and strong communication skills. They should also have a strong understanding of biotechnology principles and processes. Certifications such as Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or Regulatory Affairs Certification (RAC) are often required. Prior roles that can lead to a Manager of Quality Assurance and Regulatory Affairs include Quality Assurance Specialist, Regulatory Affairs Associate, and Quality Control Supervisor.
The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients...
Environmental Lab Manager (Instruction & Classroom Support Technician 2)
- Mount Vernon, WA
- 90+ days ago
- Mount Vernon, WA
- 90+ days ago
This position works in the Biology Department on the main campus located in Mount Vernon, Washington....
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Required or preferred licenses and certifications for Manager of Quality Assurance and Regulatory Affairs positions.
Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Washington offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Quality Assurance and Regulatory Affairs position
- Mentoring
- Continuous Improvement
- Affirmative Action
- Quality Systems
- Implementation
- Quality Management
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Animal Models
- Spectrophotometer
- Gene Therapy
- Proteomics
- ICH Guidelines
- Lab Safety
- Neurobiology
- Molecular Biology
- Clinical Laboratory Operations
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Experimental Design
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Education Experience
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Policy Development
- Bachelor's Degree
- Inventory Management
- Regulations
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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