Manager of Quality Assurance and Regulatory Affairs Jobs in Hawaii
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.
Title: Lab Manager Position Number: 0096571 Hiring Unit: College of Natural & Health Sciences (CNHS)/Marine Science Location: UH Hilo Date Posted: April 2, 2025 Closing Date: April 15, 2025 Band:...
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Hawaii 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
- Affirmative Action
- Quality Systems
- Implementation
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- TrackWise
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Biomarkers
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Genotyping
- Lab Safety
- Cell Culture
- Cloning
- Molecular Biology
- Clinical Laboratory Operations
- Polymerase Chain Reaction
- DNA Isolation
- Drug Development
- Western Blot
- Biology
- Pharmacovigilance
- Microbiology
- Stem Cells
- Microscopy
- Good Laboratory Practice
- Scientific Writing
- Clinical Trials
- Biotechnology
- Laboratory Management
- Medical Device Sales
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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