Quality Assurance Specialist Jobs in Colorado
A Quality Assurance (QA) Specialist in the biotechnology industry is responsible for ensuring that the biomedical products, pharmaceuticals, and medical devices produced meet strict quality standards. They conduct routine audits, develop quality control procedures, and oversee the manufacturing process to ensure compliance with legal regulations and industry standards. QA Specialists also assist in problem-solving efforts relating to quality management and perform regular inspections, documenting any discrepancies and implementing corrective actions when necessary.
A strong candidate for a QA Specialist typically requires a bachelor's degree in biology, chemistry, or a related field. They should have excellent attention to detail, strong communication skills, and the ability to work in a regulated environment. A working knowledge of FDA regulations, ISO standards, and GMP (Good Manufacturing Practices) is often required. Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Certified Quality Improvement Associate (CQIA) are relevant certifications. Prior to becoming a QA Specialist, a person might have roles such as a Lab Technician, Quality Control Analyst, or Research Associate in the biotechnology field.
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our...
Quality Assurance Associate I-III (In Plant Operations)
- Boulder, CO
- 4 days ago
- Boulder, CO
- 4 days ago
Understanding of basic scientific/technical concepts EDUCATION and/or EXPERIENCE Bachelors degree in Biology, Chemistry or other relevant science/engineering discipline or equivalent work experience...
Principal Regulatory Affairs Specialist/Engineer (SaMD)
- Denver, CO
- 30+ days ago
- Denver, CO
- 30+ days ago
Principal Regulatory Affairs Specialist/Engineer (SaMD) Principal Regulatory Affairs Specialist/Engineer (SaMD) Virtual US About Cleerly We're Cleerly - a healthcare company that's revolutionizing...
Proficient knowledge of cGMP practices, regulatory and ICH guidelines....
Senior Environmental Compliance Specialist
- Grand Junction, CO
- 60+ days ago
- Grand Junction, CO
- 60+ days ago
Required Education and Years of Relevant Experience Bachelors Degree in E nvironmental Science, Biology, Ecology, History, or related field....
Required Education and Years of Relevant Experience Bachelors Degree in E nvironmental Science, Biology, Ecology, History, or related field. Experience in lieu of education will be considered....
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Highest Education Level
Quality Assurance Specialists in Colorado offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Verbal Communication
- Filing
- Environmental Compliance
- NEPA
- CERCLA
- Environmental Management
- Quality Systems
- ISO Certified
- Implementation
- Air Quality
- Inspections
- ISO 13485
- Clean Water Act
- Environmental Education
- Clean Air Act
- Natural Resource Management
- ISO 14001
- Certified Hazardous Materials Manager
- Internal Audits
- GxP
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Clinical Data Management
- Good Clinical Practice
- Gene Therapy
- ICH Guidelines
- Field Sampling
- Biology
- Ecology
- Pharmacovigilance
- Good Laboratory Practice
- Biotechnology
- Clinical Trials
- Clinical Research
- Environmental Science
- Genetics
- FDA Regulations
- Medical Device Sales
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Microsoft PowerPoint
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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