Manager of Quality Assurance and Regulatory Affairs Jobs in Cincinnati, OH
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.
Director, Quality Assurance/Regulatory Affairs, Hoxworth Blood Center University of Cincinnati
- Cincinnati, OH
- 8 days ago
- Cincinnati, OH
- 8 days ago
Current UC employees must apply internally via SuccessFactors Founded in 1819, the University of Cincinnati ranks among the nation?s best urban public research universities. Home to 53,235...
Director, Quality Assurance/Regulatory Affairs, Hoxworth Blood Center
- Cincinnati, OH
- 8 days ago
- Cincinnati, OH
- 8 days ago
Current UC employees must apply internally via SuccessFactors Founded in 1819, the University of Cincinnati ranks among the nations best urban public research universities. Home to 53,235...
Regulatory Affairs Manager - USA
- Hebron, KY (14 miles from Cincinnati, OH)
- 11 days ago
- Hebron, KY (14 miles from Cincinnati, OH)
- 11 days ago
About Us: How many companies can say theyve been in business for over 177 years?! Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a...
Responsibilities include: Teaching lecture and/or lab for General Chemistry and a one-semester General, Organic, and Biochemistry course for allied health majors Maintaining the inventory of the chemistry...
Clinical Lab Manager - Chemistry
- Highland Heights, KY (10 miles from Cincinnati, OH)
- 45+ days ago
- Highland Heights, KY (10 miles from Cincinnati, OH)
- 45+ days ago
Work Schedule First Shift (Days) Environmental Conditions Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear...
Demographic Data for Cincinnati, OH
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Manager of Quality Assurance and Regulatory Affairss in Cincinnati, OH 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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