Manager of Quality Assurance and Regulatory Affairs Jobs in Texas
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....
Experience with lab safety audits and adhering to safety standards and protocols in order to maintain compliance. 8....
Associate Director of Quality Assurance Operations Kelly Science & Clinical is seeking an Associate Director of Quality Assurance Operations for one of our clients, a biotech company, located in...
Biology Spec-ASCP (SMB):....
Assign responsibilities to manage testing Provide coaching and training to technicians on lab safety and operations Escalate quality issues to management and quality engineering team Lead 5S and efficiency...
WHY UT SOUTHWESTERN? With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and...
Research Engineering/Scientist Associate II (Lab Manager)
- Austin, TX
- 19 days ago
- Austin, TX
- 19 days ago
Strong technical expertise in a wide range of laboratory techniques, such as optical imaging, electrophysiology and/or molecular biology....
This is a full-time, on-site role for a Quality Assurance Director at Slovacek Foods, LP. The Quality Assurance Director will be responsible for overseeing the quality control processes,...
ASCP certification in Molecular Biology (MB) preferred. Bachelor's Degree with emphasis in medical technology, chemical or biological science required....
Perform experiments using molecular biology, biochemistry, animal surgery, data analysis....
About CTMC CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, and located in the renowned Texas Medical Center. Our mission is to accelerate...
Manager, Regulatory Affairs - Americas Lewisville, TX, United States JOB DESCRIPTION Main Tasks and Responsibilities The following is a detailed, but not exhaustive, listing of the tasks you will...
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 ---...
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Manager of Quality Assurance and Regulatory Affairss in Texas 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
- Quality Systems
- Supplier Management
- Implementation
- Interpersonal Skills
- Inspections
- Quality Management Systems
- Batch Record Review
- GxP
- Food Manufacturing
- 21 CFR 820
- Institutional Review Board
- Cell Biology
- Assay Development
- Transfection
- Real-Time Polymerase Chain Reaction
- Gene Therapy
- ICH Guidelines
- Genotyping
- Good Clinical Practice
- Lab Safety
- Molecular Biology
- Tissue Culture
- Polymerase Chain Reaction
- Pharmacovigilance
- Clinical Laboratory Operations
- Cell Culture
- DNA Isolation
- Drug Development
- Medical Writing
- Microbiology
- Biology
- Stem Cells
- Immunology
- DNA/RNA Extraction
- Microscopy
- Good Laboratory Practice
- Biotechnology
- Laboratory Management
- Validation
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Inventory Management
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Problem Solving
- Teamwork
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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