Manager of Quality Assurance and Regulatory Affairs Jobs in Saint Louis, MO
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.
Scheduled Hours 40 Position Summary Serves as quality and safety leader for department's Neuromuscular Clinical Laboratory ensuring the effectiveness and proper execution of procedures, processes...
Manager Quality Assurance I - Neurology Washington University in St. Louis
- Saint Louis, MO
- 2 days ago
- Saint Louis, MO
- 2 days ago
Scheduled Hours 40 Position Summary Serves as quality and safety leader for departmentas Neuromuscular Clinical Laboratory ensuring the effectiveness and proper execution of procedures, processes...
Minimum Qualifications Bachelor's degree in biology, biomedical sciences, or a related field Minimum of 3 years of hands-on experience in histology and microscopy....
Minimum Qualifications Bachelors degree in biology, biomedical sciences, or a related field Minimum of 3 years of hands-on experience in histology and microscopy....
Skills Molecular Biology Techniques: Skills in techniques such as PCR, Western blotting, ELISA, immunohistochemistry, and gene expression analysis to study molecular changes in response to light pollution...
Research Lab Manager - Neurosurgery Washington University in St. Louis
- Saint Louis, MO
- 24 days ago
- Saint Louis, MO
- 24 days ago
Scheduled Hours 40 Position Summary The Roland Lab is seeking an enthusiastic Research Lab Manager to join our study of brain networks in development and pathological conditions. Our work...
Scheduled Hours 40 Position Summary The Roland Lab is seeking an enthusiastic Research Lab Manager to join our study of brain networks in development and pathological conditions. Our work...
Scheduled Hours 40 Position Summary Serves as quality and safety leader for departments Neuromuscular Clinical Laboratory ensuring the effectiveness and proper execution of procedures, processes...
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Manager of Quality Assurance and Regulatory Affairss in Saint Louis, MO 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
- Change Control
- Interpersonal Skills
- Quality Management Systems
- Batch Record Review
- GxP
- 21 CFR 820
- Institutional Review Board
- Assay Development
- Flow Cytometry
- Good Clinical Practice
- Real-Time Polymerase Chain Reaction
- Tissue Culture
- Gene Therapy
- ICH Guidelines
- Genotyping
- Lab Safety
- Molecular Biology
- Cloning
- Clinical Laboratory Operations
- Cancer Biology
- Polymerase Chain Reaction
- Western Blot
- DNA Isolation
- Drug Development
- Biology
- Medical Writing
- Pharmacovigilance
- Stem Cells
- Microbiology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Scientific Writing
- Biotechnology
- Laboratory Management
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Collections
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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