Director of Quality Assurance and Regulatory Affairs Jobs in Texas
A Director of Quality Assurance and Regulatory Affairs in the biotechnology industry is essentially responsible for developing and implementing systems that ensure products meet quality standards and regulatory requirements. This includes conducting internal audits, leading investigations into quality issues, liaising with regulatory bodies, and overseeing the submission of regulatory documents. They are also responsible for ensuring compliance with regulatory requirements and standards such as ISO, FDA, and EMEA. They play a crucial role in maintaining the company's reputation and ensuring customer satisfaction by ensuring that products are safe, reliable, and meet both customer and regulatory requirements.
Key skills for this role include strong analytical and problem-solving skills, excellent communication skills, and a strong knowledge of the biotechnology industry and its associated regulations. They should also have strong leadership skills, as they will often be leading teams and coordinating with other departments. Important certifications may include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Regulatory Affairs Certification (RAC), or Certified Quality Manager (CQM). Prior to becoming a Director of Quality Assurance and Regulatory Affairs, an individual may have roles such as Quality Assurance Manager, Regulatory Affairs Specialist, or Senior Quality Engineer within the industry.
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....
Supervise the operations of laboratory facility services and laboratory materials storeroom, which maintain and support a wide variety of laboratory and field programs. In-person work on campus is...
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):....
Current Dallas College employees will need to log into Workday through My Apps to apply. Simply enter "Find Jobs" in the Workday search bar to view open positions and submit your application. All...
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...
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
- 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....
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...
Basic Requirements: Must be a Christian who is a member of a church that acknowledges Jesus Christ as Lord and Savior and recognizes solely the Old Testament and the New Testament as sacred...
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...
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Director 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 Director 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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