Compliance Specialist Jobs in Rtp, NC
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.
Manufacturing Compliance Specialist I/II
- Durham, NC (6 miles from Rtp, NC)
- 7 days ago
- Durham, NC (6 miles from Rtp, NC)
- 7 days ago
Salary Range: Manufacturing Compliance Specialist I: $63,000 - $86,900 ; Manufacturing Compliance Specialist II: $74,000 - $115,500.00 Salary range provided per current averages and expectations....
Manufacturing Compliance Specialist I/II (Nights)
- Durham, NC (6 miles from Rtp, NC)
- 16 days ago
- Durham, NC (6 miles from Rtp, NC)
- 16 days ago
JOB SUMMARY: The incumbent will support GMP downstream manufacturing operations for late-phase and commercial mammalian Cell Culture programs and oversee compliance activities for the department....
- Durham, NC (6 miles from Rtp, NC)
- 23 days ago
- Durham, NC (6 miles from Rtp, NC)
- 23 days ago
Job Description Summary This position will be located at Durham, NC and will not have the ability to be located remotely. The Sterility Assurance Lead serves as the key functional expert for...
Senior GPS Quality, Training & Compliance Manager
- Durham, NC (6 miles from Rtp, NC)
- 45+ days ago
- Durham, NC (6 miles from Rtp, NC)
- 45+ days ago
United Therapeutics Senior GPS Quality, Training & Compliance Manager in Research Triangle Park , North Carolina California, US residents click here (. The job details are as follows: Who we are...
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Senior Corporate Compliance Manager - Training, Communications & Policy
- Rtp, NC
- 60+ days ago
- Rtp, NC
- 60+ days ago
California, US residents click here. The job details are as follows: Who we are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation....
- Morrisville, NC (4 miles from Rtp, NC)
- 60+ days ago
- Morrisville, NC (4 miles from Rtp, NC)
- 60+ days ago
Background: The ideal candidate will have a bachelors degree in a science-related or engineering discipline such as Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Chemistry, or Biology...
Demographic Data for Rtp, NC
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Salary for Compliance Specialist Jobs in Rtp, NC
Highest Education Level
Compliance Specialists in Rtp, NC offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Compliance Specialist position
- Verbal Communication
- Environmental Compliance
- Waste Management
- Environmental Management
- Affirmative Action
- Quality Systems
- ISO Certified
- Geology
- Implementation
- Air Quality
- Inspections
- ISO 13485
- Environmental Education
- Natural Resource Management
- ISO 14001
- Environmental Engineering
- Certified Hazardous Materials Manager
- GxP
- TrackWise
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Clinical Data Management
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Field Sampling
- Drug Development
- Biology
- Pharmacovigilance
- Good Laboratory Practice
- Biotechnology
- Clinical Trials
- Environmental Science
- Clinical Research
- Genetics
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Engineering
- Strategy Development
- Risk Management
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Microsoft PowerPoint
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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