Compliance Specialist Remote & Hybrid Only Jobs in North Carolina
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.
Global CDMO Compliance Officer
- FUJIFILM Diosynth Biotechnologies
- Morrisville, NC
- 27 days ago
- Morrisville, NC
- 27 days ago
Position Overview FUJIFILM Holdings America Corporation is seeking an accomplished, talented, and highly motivated individual to serve as Global CDMO Compliance Officer for its FUJIFILM...
HybridSr QMS AI Quality & Compliance Specialist- fully remote!
- Thermo Fisher Scientific
- NC
- 30+ days ago
- NC
- 30+ days ago
The QMS AI Quality & Compliance Specialist is a Quality role responsible for supporting the implementation and operation of Thermo Fisher Scientific's AI Compliance Program within GxP-regulated environments...
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Highest Education Level
Compliance Specialists in North Carolina offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Compliance 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
- Microsoft PowerPoint
- 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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