Quality Assurance Specialist Jobs in California
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 PersonOR Masters degree in life science or related field AND Some experience as noted above Demonstrated understanding of Good Clinical Practices (GCP), regulatory compliance and inspection readiness Strong...
In PersonRegulatory Affairs Coordinator
- University of California System
- Orange, CA
- 25 days ago
- Orange, CA
- 25 days ago
in accordance with Good Clinical Practice (GCP), internal standard operating procedures (SOPs), and University policies....
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 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 Danahers 15+ operating...
In PersonRequired: Strong knowledge of cGMP regulations (21 CFR Parts 210/211) and ICH guidelines (Q7, Q9, Q10). Experience with risk-based audit programs and inspection readiness activities....
In Person- PCI Pharma Services
- San Diego, CA
- 30+ days ago
- San Diego, CA
- 30+ days ago
Required: - Strong knowledge of cGMP regulations (21 CFR Parts 210/211) and ICH guidelines (Q7, Q9, Q10). - Experience with risk-based audit programs and inspection readiness activities. - Bachelors...
In PersonSr. Compliance Specialist (Regulated Industry)
- Mentor Technical Group
- Redwood City, CA
- 30+ days ago
- Redwood City, 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 PersonJob 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 PersonWe’d Like You to Have A B.S. degree, preferably in molecular biology, biology, biomedical engineering, chemistry or a related life science discipline....
In Person- Neurocrine Biosciences Inc.
- San Diego, CA
- 60+ days ago
- San Diego, CA
- 60+ days ago
Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are...
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Moving to California? Find some basic demographic data about California below.
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Salary for Quality Assurance Specialist Jobs in California
Highest Education Level
Quality Assurance Specialists in California offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Filing
- 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
- Cancer Research
- 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
- Auditing
- Written Communication
- Investigation
- Quality Assurance
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Collaboration
- Education Experience
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Excel
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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