Manager of Quality Assurance and Regulatory Affairs Jobs in Lincolnshire, 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.
Lab Manager- Quality Control/Microbiology
- Mundelein, IL (8 miles from Lincolnshire, IL)
- 4 hours ago
- Mundelein, IL (8 miles from Lincolnshire, IL)
- 4 hours ago
Preferred Qualifications: Education Bachelors degree in Microbiology, Biology, Engineering or Chemistry. At least 4 years of pharmaceutical, medical device or cosmetic GMP laboratory experience....
Director, Regulatory Affairs Strategy
- Chicago, IL (23 miles from Lincolnshire, IL)
- 1 day ago
- Chicago, IL (23 miles from Lincolnshire, IL)
- 1 day ago
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
- Chicago, IL (23 miles from Lincolnshire, IL)
- 4 days ago
- Chicago, IL (23 miles from Lincolnshire, IL)
- 4 days ago
developed through**Certifications:****\-\--****Preferred Qualifications****Education**- A bachelor\'s degree (or higher) in neuroscience, cognitive science, computer science, psychology, sociology, biology...
Manager, Regulatory Affairs US Advertising and Promotion - Immunology
- Mettawa, IL (4 miles from Lincolnshire, IL)
- 4 days ago
- Mettawa, IL (4 miles from Lincolnshire, IL)
- 4 days ago
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required Qualifications Minimum: Bachelor's degree in science (biology, chemistry...
Manager/Senior Manager, Regulatory Affairs - CDx
- Chicago, IL (23 miles from Lincolnshire, IL)
- 12 days ago
- Chicago, IL (23 miles from Lincolnshire, IL)
- 12 days ago
Minimum of 5+ years of experience in Regulatory Affairs experience related to medical devices Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop...
Remote Work- Chicago, IL (23 miles from Lincolnshire, IL)
- 14 days ago
- Chicago, IL (23 miles from Lincolnshire, IL)
- 14 days ago
Department BSD CCC - CCT Pod1 About the Department The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the...
Regulatory Affairs Manager (Regulatory Systems Specialist)
- Chicago, IL (23 miles from Lincolnshire, IL)
- 15 days ago
- Chicago, IL (23 miles from Lincolnshire, IL)
- 15 days ago
Regulatory Affairs Manager II 12 Month Contract | REMOTE Join a leading biopharma company supporting critical regulatory systems initiatives. We're seeking a detail-oriented consultant with...
Regulatory Affairs Manager - JR29338-3800
- Chicago, IL (23 miles from Lincolnshire, IL)
- 15 days ago
- Chicago, IL (23 miles from Lincolnshire, IL)
- 15 days ago
The University of Chicago Regulatory Affairs Manager - JR29338-3800 in Chicago , Illinois This job was posted by : For more information, please see: Department BSD CCC - CCT Pod1 About the...
- Chicago, IL (23 miles from Lincolnshire, IL)
- 19 days ago
- Chicago, IL (23 miles from Lincolnshire, IL)
- 19 days ago
Regulatory Affairs Manager II#25-53978 Chicago, IL Fully Remote Job Description 100% Remote (EST time zone) 12 months *** per hour max bill rate Performs eCTD submission management across ***'s...
Remote Work- Chicago, IL (23 miles from Lincolnshire, IL)
- 30+ days ago
- Chicago, IL (23 miles from Lincolnshire, IL)
- 30+ days ago
Knowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
- Chicago, IL (23 miles from Lincolnshire, IL)
- 30+ days ago
- Chicago, IL (23 miles from Lincolnshire, IL)
- 30+ 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...
Lab Manager University of Chicago (UC)
- Chicago, IL (23 miles from Lincolnshire, IL)
- 30+ days ago
- Chicago, IL (23 miles from Lincolnshire, IL)
- 30+ days ago
Knowledge of research techniques or methods (cell biology, translation, transcription, primary cultures, microscopy, cell assays, biochemical assays, molecular biology assays)....
Lab Manager Operations - Histology
- Winfield, IL (24 miles from Lincolnshire, IL)
- 45+ days ago
- Winfield, IL (24 miles from Lincolnshire, IL)
- 45+ days ago
Qualifications Required: Bachelor of Science in Medical Technology, Biology or Chemistry or an Associates Degree in a Laboratory Science or Medical Laboratory Technology....
Overview Find a Better Way... ...to use your skills and experience. This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the...
Overview Find a Better Way... ...to use your skills and experience. This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the...
Demographic Data for Lincolnshire, IL
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Lincolnshire, 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
- 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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