Quality Assurance Specialist Jobs in Fremont, CA
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.
QMS Compliance Manager - IVD cGMP
- Cytek Biosciences Inc.
- Fremont, CA
- 5 days ago
- Fremont, CA
- 5 days ago
At Cytek Biosciences, we're transforming the future of flow cytometry. As a global leader in spectral technology, our advanced platforms enable deeper scientific discovery, empowering researchers...
In PersonBring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Molecular Devices, one of Danaher's 15+ operating...
In Person- Danaher Corporation
- San Jose, CA (16 miles from Fremont, CA)
- 28 days ago
- San Jose, CA (16 miles from Fremont, CA)
- 28 days ago
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Molecular Devices, one of Danahers 15+ operating...
In PersonSr. Compliance Specialist (Regulated Industry)
- Mentor Technical Group
- Redwood City, CA (15 miles from Fremont, CA)
- 30+ days ago
- Redwood City, CA (15 miles from Fremont, CA)
- 30+ days ago
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical...
In Person- System One
- Mountain View, CA (11 miles from Fremont, CA)
- 30+ days ago
- Mountain View, CA (11 miles from Fremont, CA)
- 30+ days ago
Job Title: Compliance Specialist III Location: Sunnyvale, California Type: 6 month contract Compensation: $25/HOUR Contractor Work Model: Onsite Hours: 40.0 Overview This role supports quality and...
In Person- Visby Medical
- San Jose, CA (16 miles from Fremont, CA)
- 30+ days ago
- San Jose, CA (16 miles from Fremont, CA)
- 30+ days ago
We’d Like You to Have A B.S. degree, preferably in molecular biology, biology, biomedical engineering, chemistry or a related life science discipline....
In PersonDemographic Data for Fremont, CA
Moving to Fremont, CA? Find some basic demographic data about Fremont, CA below.
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Salary for Quality Assurance Specialist Jobs in Fremont, CA
Highest Education Level
Quality Assurance Specialists in Fremont, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Environmental Compliance
- Environmental Planning
- Water Quality
- Inspections
- ISO 13485
- Clean Water Act
- National Pollutant Discharge Elimination System
- Batch Record Review
- GxP
- 21 CFR 820
- Molecular Biology
- Good Clinical Practice
- ICH Guidelines
- Institutional Review Board
- ICH GCP
- Biomedical Engineering
- Lab Safety
- Genomics
- Gene Therapy
- Biochemistry
- Environmental Monitoring
- Microbiology
- Biology
- Good Laboratory Practice
- Ecology
- Environmental Science
- Clinical Trials
- Clinical Research
- Biotechnology
- Laboratory Management
- Medical Device Sales
- FDA Regulations
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Diagnostic
- Technical Writing
- Strategy Development
- Engineering
- Quality Control
- Military Background
- Auditing
- Written Communication
- Investigation
- Quality Assurance
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Collaboration
- Education Experience
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Excel
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Leadership
- Communication Skills
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