Compliance Specialist Jobs in Michigan
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.
Research Compliance Specialist Lead
- University of Michigan
- Ann Arbor, MI
- 5 days ago
- Ann Arbor, MI
- 5 days ago
Review Board (IRB), Human Research Protection Program (HRPP) related units, Clinical Trials Support Units, Regulatory Affairs, Office of General Counsel and others as needed, including eResearch review...
In PersonResearch Compliance Specialist Senior
- University of Michigan
- Ann Arbor, MI
- 30+ days ago
- Ann Arbor, MI
- 30+ days ago
trial experience, or an equivalent combination of education and work experience in an academic research setting Minimum 3 years of experience in monitoring clinical trials in an academic or industry...
In Person- Grand River Aseptic Manufacturing
- Grand Rapids, MI
- 60+ days ago
- Grand Rapids, MI
- 60+ days ago
Overview of this Position: The Senior Compliance Specialist supports the development, implementation, and maintenance of relevant quality system initiatives in support of their function....
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Compliance Specialists in Michigan 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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