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.
Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Honolulu, HI
- 3 days ago
- Honolulu, HI
- 3 days ago
This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is to ensure...
Academic Support (Greenhouse/Aquaculture Lab Manager, 0096717T)
- Pearl City, HI
- 10 days ago
- Pearl City, HI
- 10 days ago
Title: Academic Support (Greenhouse/Aquaculture Lab Manager) Position Number: 0096717T Hiring Unit: Biological Science Location: Leeward Community College Date Posted: June 17, 2025 Closing Date:...
California, US residents click here (. **The job details are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit...
We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, were all a part of something bigger than...
Assistant Lab Manager (Full-Time) - Maui Memorial Medical Center, Wailuku, HI
- Wailuku, HI
- 45+ days ago
- Wailuku, HI
- 45+ days ago
Job Functions, Duties, Responsibilities and Position Qualifications: We're not just a workplace - we're a Great Place to Work certified employer! Proudly certified as a Great Place to Work, we are...
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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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
- English
- Mentoring
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Quality Management
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Neurobiology
- Lab Safety
- Molecular Biology
- Genotyping
- Protein Purification
- Drug Development
- Biochemistry
- Biology
- Immunology
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Neuroscience
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Corrective Actions & Preventive Actions
- Research and Development
- Process Development
- Standard Operating Procedures
- Diagnostic
- Masters In Education
- Data Management
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Bachelor's Degree
- Regulations
- Inventory Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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