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.
Pharmacovigilance Compliance Manager
- Raleigh, NC (16 miles from Rtp, NC)
- 13 days ago
- Raleigh, NC (16 miles from Rtp, NC)
- 13 days ago
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing...
- Durham, NC (6 miles from Rtp, NC)
- 20 days ago
- Durham, NC (6 miles from Rtp, NC)
- 20 days ago
Quality Assurance Associate II Title: QA Associate II Location: Durham, NC Industry: Pharmaceutical Salary: $33/hr. and up based on experience Employment Type: Contract We are a technology-forward...
- Durham, NC (6 miles from Rtp, NC)
- 45+ days ago
- Durham, NC (6 miles from Rtp, NC)
- 45+ days ago
The AFS Compliance Specialist II will track and monitor AFS quality records (e.g., deviations, CAPAs, change controls, laboratory investigations, etc.) for on-time closure and trends and report this...
Facilities Compliance Specialist II
- Durham, NC (6 miles from Rtp, NC)
- 45+ days ago
- Durham, NC (6 miles from Rtp, NC)
- 45+ days ago
Job Summary: The Facilities Compliance Specialist II supports the Facilities Engineering Department as a part of a rapidly expanding GMP Contract Manufacturing Operation....
- Durham, NC (6 miles from Rtp, NC)
- 90+ days ago
- Durham, NC (6 miles from Rtp, NC)
- 90+ 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...
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....
Demographic Data for Rtp, NC
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Salary for Compliance Specialist Jobs in Rtp, NC
Required or preferred licenses and certifications for Compliance Specialist positions.
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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
- Filing
- Quality Systems
- Water Quality
- Implementation
- Groundwater
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Clean Water Act
- GxP
- TrackWise
- 21 CFR 820
- ICH GCP
- Institutional Review Board
- Lab Safety
- Good Clinical Practice
- ICH Guidelines
- Medical Affairs
- Biology
- Ecology
- Microbiology
- Drug Development
- Pharmacovigilance
- Environmental Monitoring
- Biotechnology
- Good Laboratory Practice
- Analytical Chemistry
- Clinical Trials
- Toxicology
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Product Development
- Technical Writing
- Engineering
- Strategy Development
- Quality Control
- Auditing
- Written Communication
- Documentation
- Education Experience
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Interpersonal Skills
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Regulations
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Microsoft Word
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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