Manager of Quality Assurance and Regulatory Affairs Jobs in Austin, TX
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.
About Onnit: Onnit is an Austin, TX-based supplement company dedicated to supporting everyday heroesthose who need to be fully present and at their best, not only for themselves but also for their...
What You Bring: PhD or masters degree in Biological Sciences, Molecular biology, Biochemistry, Cell Biology, Plant Biology, Agricultural Sciences or related disciplines....
We are looking for a highly energetic and motivated Quality Control Supervisor to lead a team of Lab Technicians at Tesla's newly built Cathode production facility in Gigafactory Texas, Austin. In...
Research Engineering/Scientist Associate II (Lab Manager)
- Austin, TX
- 16 days ago
- Austin, TX
- 16 days ago
Strong technical expertise in a wide range of laboratory techniques, such as optical imaging, electrophysiology and/or molecular biology....
Perform experiments using molecular biology, biochemistry, animal surgery, data analysis....
What You'll Do ECS Limited is offering a unique opportunity for a talented and certified Assistant Lab Manager to join our Austin team. We offer opportunities for professional development with...
Job Posting Title: Lab Manager - Williamson --- Hiring Department: Population Research Center --- Position Open To: All Applicants --- Weekly Scheduled Hours: 40 --- FLSA Status: Non-Exempt ---...
What You'll Do ECS Limited is offering a unique opportunity for a talented and certified Assistant Concrete Lab Manager to join our Austinteam. We offer opportunities for professional development...
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Manager of Quality Assurance and Regulatory Affairss in Austin, TX 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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