Manager of Quality Assurance and Regulatory Affairs Jobs in Ohio
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.
Department:107000 RegulatoryLocation:USA- RemoteBe a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we...
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...
Walmart (USA) Area Manager, Quality Assurance/Systems in Groveport , Ohio Position Summary... What you'll do... Implements the business plan for assigned area of responsibility by communicating...
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...
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...
Essential Skills Experience in life science, biotechnology, or molecular biology. Proficiency in GMP, FDA, and quality assurance standards. Relevant four-year degree, Master's, or PhD preferred....
JOB TITLE MANAGER, QUALITY ASSURANCE QUALITY OPERATIONS Department Quality Assurance Quality Operations Reports To Director, Quality Assurance or above Ladder Level - 5 DESCRIPTION Position...
Labcorp is seeking a Clinical Laboratory Manager to join our team in Dublin, OH. This position will be responsible for overseeing the operations and administration of the clinical laboratory...
The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in...
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Manager of Quality Assurance and Regulatory Affairss in Ohio 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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