Compliance Specialist Jobs in Durham, 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.
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...
Job Summary: The Facilities Compliance Specialist II supports the Facilities Engineering Department as a part of a rapidly expanding GMP Contract Manufacturing Operation....
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....
- Raleigh, NC (21 miles from Durham, NC)
- 30+ days ago
- Raleigh, NC (21 miles from Durham, NC)
- 30+ days ago
RWD Compliance Manager Company: Norstella Location: Remote, United States Date Posted: May 23, 2025 Employment Type: Full Time Job ID: R-1204 **Description** **About Norstella:** At Norstella, our...
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
- Rtp, NC (6 miles from Durham, NC)
- 90+ days ago
- Rtp, NC (6 miles from Durham, NC)
- 90+ 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....
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Compliance Specialists in Durham, NC offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Compliance Specialist position
- English
- Driving
- Environmental Compliance
- Quality Systems
- ISO Certified
- Geology
- Implementation
- Air Quality
- Document Control
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Environmental Education
- Batch Record Review
- GxP
- TrackWise
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- ICH Guidelines
- Good Clinical Practice
- Lab Safety
- Biology
- Drug Development
- Microbiology
- Environmental Monitoring
- Biotechnology
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Data Science
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Machine Learning
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Military Background
- Auditing
- Investigation
- Written Communication
- Interpersonal Skills
- Quality Assurance
- Collaboration
- Education Experience
- Documentation
- Reporting
- Bachelor's Degree
- Regulations
- Policy Development
- Microsoft Office
- Problem Solving
- Sales
- Research Skills
- Organization
- Scheduling
- Leadership
- Communication Skills
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