Compliance Specialist Jobs in Pleasanton, CA
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.
- Palo Alto, CA (21 miles from Pleasanton, CA)
- 2 days ago
- Palo Alto, CA (21 miles from Pleasanton, CA)
- 2 days ago
Company Description Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is...
This is the century of biology, and the breakthroughs we make now have the potential to change the world....
Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)
- Milpitas, CA (15 miles from Pleasanton, CA)
- 28 days ago
- Milpitas, CA (15 miles from Pleasanton, CA)
- 28 days ago
Influences middle management on technical or business solutions Required Qualifications Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology,...
Regulatory Affairs Specialist - Pleasanton, CA
- Pleasanton, CA
- 28 days ago
- Pleasanton, CA
- 28 days ago
Clinical Practices (GCPs)....
Vice President, Compliance Officer
- Redwood City, CA (24 miles from Pleasanton, CA)
- 30+ days ago
- Redwood City, CA (24 miles from Pleasanton, CA)
- 30+ days ago
About Soleno Therapeutics Inc Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare...
Clinical Research Project and Quality & Compliance Manager, Emergency Medicine (Hybrid Opportunity)
- Stanford, CA (23 miles from Pleasanton, CA)
- 90+ days ago
- Stanford, CA (23 miles from Pleasanton, CA)
- 90+ days ago
Expert knowledge of regulatory affairs, including IRB review and approval process and Good Clinical Practice. Knowledge of International Conference on Harmonization (ICH) standards....
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Compliance Specialists in Pleasanton, CA 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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