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.
The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients...
Principal Scientist (Director) - Regulatory Affairs-CMC
- Lincoln, NE
- 13 days ago
- Lincoln, NE
- 13 days ago
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...
See Minimum Required Qualifications Bachelor's degree in Biology and 1 year of laboratory experience. Strong experience with molecular biology and ordering supplies....
Research Technologist-Lab Manager University of Nebraska Lincoln
- Lincoln, NE
- 21 days ago
- Lincoln, NE
- 21 days ago
Minimum Required Qualifications: Bachelor's degree in Biology and 1 year of laboratory experience. Strong experience with molecular biology and ordering supplies....
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...
Minimum Requirements Bachelors Degree in Biology, Chemistry, or related field from an accredited college or university....
Who You Are: Bachelor's degree in food science, Biology, Chemistry, or related discipline....
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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
- Continuous Improvement
- Affirmative Action
- Quality Systems
- Implementation
- Quality Management
- Document Control
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- ICH GCP
- Animal Models
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Neurobiology
- Molecular Biology
- Biology
- Biochemistry
- Drug Development
- Immunology
- Microbiology
- Immunohistochemistry
- Biotechnology
- Laboratory Management
- Equipment Calibration
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Process Development
- Standard Operating Procedures
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Investigation
- Written Communication
- Education Experience
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Inventory Management
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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