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.
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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...
Regulatory Affairs Manager - Electrophysiology (on-site)
- Plymouth, MN
- 21 days ago
- Plymouth, MN
- 21 days ago
Preferred Qualifications Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields....
#LI-LS3 #LI-ONSITE Keywords: 401k, 401k match, pto, paid time off, holiday, medical, dental, health, culture, reg affairs, regulatory affair, regulatory affairs, biotech, biotechnology, biologic, biology...
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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 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
- Mentoring
- Quality Systems
- Implementation
- Quality Management
- Change Control
- Coaching
- Inspections
- Quality Management Systems
- Batch Record Review
- Internal Audits
- GxP
- ASQ Certified Quality Auditor
- TrackWise
- Institutional Review Board
- ICH GCP
- Assay Development
- Animal Models
- Gene Therapy
- ICH Guidelines
- Neurobiology
- Lab Safety
- Molecular Biology
- Genotyping
- Next-Generation Sequencing
- Cell Culture
- Polymerase Chain Reaction
- Drug Development
- Biochemistry
- Biology
- Immunology
- Medical Writing
- Microbiology
- Scientific Writing
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Laboratory Management
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Collaboration
- Documentation
- Quality Assurance
- Reporting
- Interpersonal Skills
- Bachelor's Degree
- Education Experience
- Regulations
- Inventory Management
- Policy Development
- Microsoft Office
- Problem Solving
- Research Skills
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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