Manager of Quality Assurance and Regulatory Affairs Jobs in Fishers, IN
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.
- Indianapolis, IN (17 miles from Fishers, IN)
- 3 days ago
- Indianapolis, IN (17 miles from Fishers, IN)
- 3 days ago
Responsible for performing responsibilities as assigned to effectively support implementation of the Quality Management System. Will provide global quality oversight for customer complaint...
Remote WorkJob Description Overview Indiana University Health is unlike any other healthcare system and we're looking for team members who share the things that matter most to us. People who are inspired by...
Partner Job Genezen Director of Quality Assurance QA QA Test Automation Indiana, United States Show interest About The field of gene therapy is growing rapidly and Genezen is here to meet the...
- Indianapolis, IN (17 miles from Fishers, IN)
- 45+ days ago
- Indianapolis, IN (17 miles from Fishers, IN)
- 45+ days ago
How You'll Add Value The Sample Preparation Services (SPS) Manager is responsible for daily processing of fresh and frozen biological samples, associated QC and characterization activities under GLP-like...
Demographic Data for Fishers, IN
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Highest Education Level
Manager of Quality Assurance and Regulatory Affairss in Fishers, IN 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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