Manager of Quality Assurance and Regulatory Affairs Jobs in Harvey, IL
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.
SUMMARY: Manages laboratory resources to ensure safe, regulatory compliance and expeditious processing of technical information and analysis in support of site objectives. Supervises and...
- Chicago, IL (20 miles from Harvey, IL)
- 2 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 2 days ago
Knowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
- Chicago, IL (20 miles from Harvey, IL)
- 6 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 6 days ago
Medical Laboratory Manager Schedule: Monday-Friday, one weekend per month One night per week, holiday rotation This rural Minnesota hospital is committed to providing high-quality, personalized...
Manager/Senior Manager, Regulatory Affairs
- Chicago, IL (20 miles from Harvey, IL)
- 6 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 6 days ago
Clinical Practice, CAP/CLIA, other quality system standards Strong communication, presentation and interpersonal skills Experience leading cross-functional teams of subject matter experts Experience...
Remote Work- Chicago, IL (20 miles from Harvey, IL)
- 8 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 8 days ago
Knowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
Lab Manager University of Chicago (UC)
- Chicago, IL (20 miles from Harvey, IL)
- 8 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 8 days ago
Knowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
Associate/Director of Regulatory Affairs (remote U
- Chicago, IL (20 miles from Harvey, IL)
- 12 days ago
- Chicago, IL (20 miles from Harvey, IL)
- 12 days ago
at PAREXEL International LLC in Chicago, Illinois, United States Job Description Exciting opportunity to join Parexel as an Associate/Director of Regulatory Affairs! As an Associate/Director of...
Remote WorkResearch Lab Manager 1 - Parker Lab
- Chicago, IL (20 miles from Harvey, IL)
- 45+ days ago
- Chicago, IL (20 miles from Harvey, IL)
- 45+ days ago
Using an advanced level of skill, completes the following activities Molecular Biology: PCR Histology: Tissue fixation/processing: embedding, preparation of blocks and sectioning, staining Immunohistochemistry...
- Chicago, IL (20 miles from Harvey, IL)
- 60+ days ago
- Chicago, IL (20 miles from Harvey, IL)
- 60+ days ago
Performs biochemical, molecular biology, and cell biology experiments. Ensures project and laboratory compliance with different policies, procedures, directives, and mandates....
Demographic Data for Harvey, IL
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Salary for Manager of Quality Assurance and Regulatory Affairs Jobs in Harvey, IL
Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Harvey, IL 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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