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.
Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering. **** **Required Experience and Skills:** + Demonstrated experience in a CMC regulatory...
You should have: B.Sc. or equivalent experience in Biology, Chemistry, bioengineering, or related science At least 5 years of IVD Regulatory Affairs experience Hands-on experience with 510(k), PMA,...
Job Posting Title: Lab Manager (Lockman) ---- Hiring Department: Population Research Center ---- Position Open To: All Applicants ---- Weekly Scheduled Hours: 40 ---- FLSA Status: Exempt ----...
Posting Number S06449P Position Title Lab Manager Functional Title Department Speech Language Hearing Salary Range $65,000 - $70,000, DOQ Pay Basis Monthly Position Status Regular full-time...
Posting Number: S06449P Department: Speech Language Hearing Salary Range: $65,000 - $70,000, DOQ Pay Basis: Monthly Position Status: Regular full-time Location: Dallas Job Description: Join Our...
Join Our Team Lab Manager Position at the UT Larynx Lab Are you passionate about voice science and eager to make a meaningful contribution to cutting-edge research? The UT Larynx Lab, led by Dr....
Under supervision, the candidate will work with cell culture of primary and immortalized cells and with in vivo with mouse models....
Biology Spec-ASCP (SMB):....
Current studies employ molecular biology (PCRs, cloning), cell biology/biochemistry (Cell culture, protein work), animal models (mouse models; tumor xenografts, genotyping) combined with unbiased metabolomics...
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...
Lab Manager, Department of Civil, Architectural and Environmental Engineering
- Austin, TX
- 45+ days ago
- Austin, TX
- 45+ days ago
Job Posting Title: Lab Manager, Department of Civil, Architectural and Environmental Engineering ---- Hiring Department: Fariborz Maseeh Department of Civil, Architectural and Environmental...
Under supervision, the candidate will work with cell culture of primary and immortalized cells and with in vivo with mouse models....
Title: Lab Manager Employee Classification: Non-Student Help - Hourly Campus: University of North Texas Division: UNT-Provost SubDivision-Department: UNT-Ryan College of Business Department:...
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...
Perform experiments using molecular biology, biochemistry, animal surgery, data analysis....
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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
- Mentoring
- Electrical Engineering
- Employee Development
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Hazardous Materials
- Quality Management
- Document Control
- Coaching
- Inspections
- ISO 13485
- Quality Management Systems
- Control Systems
- Batch Record Review
- GxP
- TrackWise
- Institutional Review Board
- Spectrophotometer
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Molecular Biology
- Genotyping
- Drug Development
- Biology
- Biochemistry
- Microbiology
- Biotechnology
- Good Laboratory Practice
- Laboratory Management
- Medical Device Sales
- Equipment Calibration
- Good Manufacturing Practices
- FDA Regulations
- Corrective Actions & Preventive Actions
- Research and Development
- Process Development
- Masters In Education
- Engineering
- Strategy Development
- Auditing
- Investigation
- Written Communication
- Quality Assurance
- Collaboration
- Documentation
- Regulations
- Inventory Management
- Project Management
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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