Director of Quality Assurance and Regulatory Affairs Jobs in Minnesota
A Director of Quality Assurance and Regulatory Affairs in the biotechnology industry is essentially responsible for developing and implementing systems that ensure products meet quality standards and regulatory requirements. This includes conducting internal audits, leading investigations into quality issues, liaising with regulatory bodies, and overseeing the submission of regulatory documents. They are also responsible for ensuring compliance with regulatory requirements and standards such as ISO, FDA, and EMEA. They play a crucial role in maintaining the company's reputation and ensuring customer satisfaction by ensuring that products are safe, reliable, and meet both customer and regulatory requirements.
Key skills for this role include strong analytical and problem-solving skills, excellent communication skills, and a strong knowledge of the biotechnology industry and its associated regulations. They should also have strong leadership skills, as they will often be leading teams and coordinating with other departments. Important certifications may include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Regulatory Affairs Certification (RAC), or Certified Quality Manager (CQM). Prior to becoming a Director of Quality Assurance and Regulatory Affairs, an individual may have roles such as Quality Assurance Manager, Regulatory Affairs Specialist, or Senior Quality Engineer within the industry.
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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Highest Education Level
Director 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 Director of Quality Assurance and Regulatory Affairs position
- Quality Systems
- Supplier Management
- Implementation
- 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
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Clinical Laboratory Operations
- Cell Culture
- DNA Isolation
- Drug Development
- Medical Writing
- Microbiology
- Biology
- Stem Cells
- Immunology
- 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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