Compliance Specialist Jobs in San Diego, 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.
OR 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 PersonCompliance Specialist supports the execution and maintenance of site compliance programs to ensure adherence to applicable regulatory requirements and company policies within PCI Pharma Services....
In Person- PCI Pharma Services
- San Diego, CA
- 30+ days ago
- San Diego, CA
- 30+ days ago
Compliance Specialist supports the execution and maintenance of site compliance programs to ensure adherence to applicable regulatory requirements and company policies within PCI Pharma Services....
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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Compliance Specialists in San Diego, 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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