Compliance Specialist Jobs in San Jose, CA
A Compliance Specialist in the biotechnology industry is responsible for ensuring that all operations, policies, and procedures adhere to relevant legal and regulatory standards. They perform regular audits, develop and implement compliance programs, review and update internal policies, and identify any potential areas of compliance vulnerability and risk. Their role is crucial in maintaining the company's integrity and protecting it from any legal issues that could arise from non-compliance. In addition, they are responsible for training and educating staff about compliance requirements and procedures.
Key skills for a Compliance Specialist include a strong knowledge of industry regulations and guidelines, excellent attention to detail, problem-solving abilities, and strong communication and organizational skills. They should ideally have a bachelor's degree in life sciences, biotechnology or a related field. Certifications such as Certified in Healthcare Compliance (CHC) or Certified Regulatory Compliance Manager (CRCM) can be advantageous. Prior to becoming a Compliance Specialist, a professional might have roles such as Compliance Analyst, Quality Assurance Associate, or Regulatory Affairs Coordinator, which provide foundational knowledge and experience in regulatory compliance and quality assurance.
QMS Compliance Manager - IVD cGMP
- Cytek Biosciences Inc.
- Fremont, CA (16 miles from San Jose, CA)
- 5 days ago
- Fremont, CA (16 miles from San Jose, 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 Person- Leica Microsystems Inc
- Fremont, CA (16 miles from San Jose, CA)
- 27 days ago
- Fremont, CA (16 miles from San Jose, CA)
- 27 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 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 PersonCompliance Specialist (Regulated Industry)
- Mentor Technical Group
- Redwood City, CA (21 miles from San Jose, CA)
- 30+ days ago
- Redwood City, CA (21 miles from San Jose, 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 (10 miles from San Jose, CA)
- 30+ days ago
- Mountain View, CA (10 miles from San Jose, CA)
- 30+ days ago
The Compliance Specialist III ensures adherence to internal procedures and external standards, including FDA and global quality regulations....
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 PersonDemographic Data for San Jose, CA
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Salary for Compliance Specialist Jobs in San Jose, CA
Highest Education Level
Compliance Specialists in San Jose, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Compliance 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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