Compliance Specialist Jobs in Kentucky
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.
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Compliance Specialists in Kentucky offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Compliance Specialist position
- English
- Accounting
- Driving
- Environmental Compliance
- Financial Services
- Quality Systems
- ISO Certified
- Geology
- Water Quality
- Implementation
- Air Quality
- Change Control
- Inspections
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- Batch Record Review
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- GxP
- TrackWise
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Good Clinical Practice
- ICH Guidelines
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- Biology
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- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Auditing
- Investigation
- Written Communication
- Education Experience
- Interpersonal Skills
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Regulations
- Policy Development
- Microsoft Office
- Problem Solving
- Research Skills
- Microsoft Excel
- Organization
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- Leadership
- Communication Skills
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