Manager of Quality Assurance and Regulatory Affairs Jobs in Nebraska
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.
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...
The Lab Manager will lead and direct all aspects of the quality control lab, as well as oversee lab safety programs and policies. The Lab Manager is responsible for maximizing plant operations to...
About the Role: We are currently seeking a motivated and detail-oriented Lab Manager to oversee laboratory operations for one of our client's facilities in the region. This is an excellent...
About the Role: We are currently seeking a motivated and detail-oriented Lab Manager to oversee laboratory operations for one of our client's facilities in the region. This is an excellent...
Quality & Sanitation Director Champion Foods, a pizza trailblazer, is expanding, and we're looking for dynamic talents to enhance our innovative and quality-driven team. We produce products...
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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 Nebraska 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
- Quality Systems
- Implementation
- Quality Management
- Change Control
- Document Management
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Institutional Review Board
- ICH GCP
- Assay Development
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Medical Affairs
- Molecular Biology
- Next-Generation Sequencing
- Polymerase Chain Reaction
- Drug Development
- Biochemistry
- Biology
- Pharmacovigilance
- Medical Writing
- Microbiology
- Microscopy
- Scientific Writing
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Laboratory Management
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Collaboration
- Documentation
- Quality Assurance
- Interpersonal Skills
- Bachelor's Degree
- Education Experience
- Regulations
- Reporting
- Inventory Management
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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