Manager of Quality Assurance and Regulatory Affairs Jobs in Arden Hills, MN
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.
Lab Manager (Research Professional 3)
- Minneapolis, MN (7 miles from Arden Hills, MN)
- 2 days ago
- Minneapolis, MN (7 miles from Arden Hills, MN)
- 2 days ago
Apply for Job Job ID365859 LocationTwin Cities Job FamilyResearch Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8353LS Employee ClassCivil Service Add to Favorite Jobs Email this Job...
- Saint Paul, MN (10 miles from Arden Hills, MN)
- 12 days ago
- Saint Paul, MN (10 miles from Arden Hills, MN)
- 12 days ago
Minimal qualifications: Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering or similar with 4+ years of related work experience. 2+ years laboratory or quality experience following cGMP...
Director, Quality Assurance Programs
- Eden Prairie, MN (15 miles from Arden Hills, MN)
- 30+ days ago
- Eden Prairie, MN (15 miles from Arden Hills, MN)
- 30+ days ago
The Director of Quality Assurance Programs has the responsibility for implementing and maintaining the internal corporate Quality Assurance Programs at Actus Nutrition. This includes Actus owned...
Rsch Pro 4-Biochemistry / Lab Manager University of Minnesota Twin Cities
- Minneapolis, MN (7 miles from Arden Hills, MN)
- 30+ days ago
- Minneapolis, MN (7 miles from Arden Hills, MN)
- 30+ days ago
Summary This is a position for a laboratory manager in the Department of Biochemistry, Molecular Biology, and Biophysics....
Rsch Pro 4-Biochemistry / Lab Manager
- Minneapolis, MN (7 miles from Arden Hills, MN)
- 30+ days ago
- Minneapolis, MN (7 miles from Arden Hills, MN)
- 30+ days ago
About the Job Summary This is a position for a laboratory manager in the Department of Biochemistry, Molecular Biology, and Biophysics....
Demographic Data for Arden Hills, MN
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Arden Hills, MN 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
- Quality Systems
- Supplier Management
- Distribution
- Implementation
- Resolution
- Safe Quality Food
- Coaching
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Assay Development
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Drug Discovery
- Pharmacovigilance
- Clinical Laboratory Operations
- DNA Isolation
- Drug Development
- Medical Writing
- Microbiology
- Biology
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Laboratory Management
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Military Background
- Troubleshooting
- Quality Control
- Investigation
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Inventory Management
- Regulations
- Teaching
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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