Manager of Quality Assurance and Regulatory Affairs Jobs in Minnesota
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.
RETROPHIN INC. Executive Director, Regulatory Affairs in Minneapolis , Minnesota Department: 107000 Regulatory Location: USA- Remote Be a part of a global team that is inspired to make a...
Serve as the lab safety Officer. * Maintain records of data per protocol requirements and submit protocols to IACUC, IBC & IRB * Attend lab meetings for all labs * Contribute to writing/editing manuscripts...
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...
Gpac has an exciting opportunity for a Quality Director position in KY. The company produces sliced meat for one of the largest big-box stores in America. This plant operates 24/7 across three...
and Research Job ID: 366735 About the Job Summary This is a position for a laboratory manager in the Department of Biochemistry, Molecular Biology, and Biophysics....
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
- 30+ days ago
- Minneapolis, MN
- 30+ days ago
Summary This is a position for a laboratory manager in the Department of Biochemistry, Molecular Biology, and Biophysics....
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Manager of Quality Assurance and Regulatory Affairss in Minnesota 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
- Quality Systems
- Supplier Management
- Implementation
- Safe Quality Food
- Interpersonal Skills
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Institutional Review Board
- Cell Biology
- Assay Development
- Transfection
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Clinical Laboratory Operations
- Cell Culture
- Genotyping
- DNA Isolation
- Drug Development
- Biochemistry
- Microbiology
- Biology
- Stem Cells
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Biotechnology
- Laboratory Management
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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