Compliance Specialist Jobs
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.
A Bachelors degree, or equivalent, in environmental science, biology, microbiology, chemistry or a related science field and two years of relevant experience are required....
Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are...
Review Board (IRB) and related regulatory support to the Principal Investigator (PI) and research team ensuring: 1) adherence to the protocol; 2) regulatory compliance; 3) protection of participant...
Minimum Education Associate's Degree Biology or a related discipline. (Required) Bachelor's Degree Biology or a related discipline....
Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) in the performance of their role....
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies Basic Minimum Qualifications: Bachelor's degree in biology...
Research Conflict of Interest %26 Conduct Compliance Analyst University of Maryland, Baltimore
- Baltimore, MD
- 18 hours ago
- Baltimore, MD
- 18 hours ago
Communicate with the Institutional Review Board (IRB) to resolve administrative modifications and address queries....
Preferred Qualifications Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields....
Requirements: Bachelors of Science in a related field such as Chemistry, Biology, Microbiology, or Food Science....
Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has...
**Education and/or Experience:** + Bachelor's degree in biology, chemistry, medical technology, medical laboratory science, clinical laboratory science or molecular biology. + Minimum of 5 years or...
Regulatory Affairs Coordinator (RAC) (Entry Senior Level)
- Sterling, VA
- 2 days ago
- Sterling, VA
- 2 days ago
Knowledge, Skills, and Abilities\: Knowledge and understanding of federal regulations and Good Clinical Practice (GCP). Ability to communicate effectively, both in writing and orally....
Research Conflict of Interest & Conduct Compliance Analyst
- Baltimore, MD
- 2 days ago
- Baltimore, MD
- 2 days ago
Communicate with the Institutional Review Board (IRB) to resolve administrative modifications and address queries....
Legal Operations & Contract Compliance Specialist
- Salt Lake City, UT
- 3 days ago
- Salt Lake City, UT
- 3 days ago
The team is looking for an energetic, creative, talented and experienced Legal Ops & Contract Compliance Specialist with a passion for managing contracts in a high-volume, fast-paced, high-performing...
Remote WorkRemote Research Regulatory Affairs Coordinator - All TxO Locations
- Dallas, TX
- 3 days ago
- Dallas, TX
- 3 days ago
Processes local and central Institutional Review Board submissions. Monitors and reports SAEs to sponsor/IRB....
Compliance Specialist Online Courses and Training Opportunities
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Highest Education Level
Compliance Specialists 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
- Quality Systems
- ISO Certified
- Water Quality
- Implementation
- Air Quality
- Inspections
- ISO 13485
- Environmental Education
- Natural Resource Management
- ISO 14001
- Environmental Engineering
- Certified Hazardous Materials Manager
- GxP
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Clinical Data Management
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Field Sampling
- Environmental Monitoring
- Biology
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Environmental Science
- Clinical Research
- Genetics
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Machine Learning
- Engineering
- Strategy Development
- Process Improvement
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Sales
- Policy Development
- Project Management
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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