Manager of Quality Assurance and Regulatory Affairs Jobs in Colorado
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.
Department:107000 RegulatoryLocation:USA- RemoteBe a part of a global team that is inspired to make a difference in the livesof people living with rare disease.At Travere Therapeutics, we...
Temporary Lab Manager 3-Month Contract Are you an experienced Lab Manager looking for a short-term opportunity? We have an exciting 3-month temporary position available in Colorado Springs, CO. If...
Temporary Lab Manager 3-Month Contract Are you an experienced Lab Manager looking for a short-term opportunity? We have an exciting 3-month temporary position available in Colorado Springs, CO. If...
ASCP Certified Lab Manager 3-Month Contract Are you an experienced Lab Manager looking for a short-term opportunity? We have a 3-month temporary position available in beautiful Rockvale, CO. If...
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe...
Core Hours: Monday - Friday, 8am-5pm Purpose and Scope The QA Operations Manager is responsible for managing Quality Assurance support for manufacturing operations, focusing on aseptic processing,...
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across...
Colorado Genetics Laboratory (CGL) Lab Manager Healthcare Manager
- Aurora, CO
- 90+ days ago
- Aurora, CO
- 90+ days ago
University of Colorado Anschutz Medical Campus Department of Pathology Colorado Genetics Laboratory (CGL) Lab Manager – Healthcare Manager Position 00831867 – Requisition 36129 Job Summary\: The...
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Manager of Quality Assurance and Regulatory Affairss in Colorado 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
- Verbal Communication
- Mentoring
- Quality Systems
- Change Control
- Coaching
- Quality Management Systems
- Batch Record Review
- GxP
- Institutional Review Board
- Assay Development
- Biomarkers
- Gene Therapy
- ICH Guidelines
- Lab Safety
- Genotyping
- Next-Generation Sequencing
- Cell Culture
- Molecular Biology
- Cloning
- Polymerase Chain Reaction
- Cancer Biology
- DNA Isolation
- Drug Development
- Biology
- Stem Cells
- Microbiology
- Clinical Trials
- Biotechnology
- Good Laboratory Practice
- Clinical Research
- Laboratory Management
- Neurology
- Oncology
- FDA Regulations
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Medical Terminology
- Engineering
- Strategy Development
- Quality Control
- Military Background
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Regulations
- Policy Development
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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