Compliance Specialist Jobs in Malvern, PA
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.
One of our large pharmaceutical clients in Malvern, PA is seeking a Compliance Specialist to join their growing team supporting the Biologics (large molecule) organization within R&D....
Senior Regulatory Affairs Specialist (Office of Clinical Research)
- Philadelphia, PA (20 miles from Malvern, PA)
- 30+ days ago
- Philadelphia, PA (20 miles from Malvern, PA)
- 30+ days ago
This position will support, train and qualify potential IND/IDE/CTA Sponsors of Investigator Initiated Trials throughout the clinical trial life cycle....
NCI/NCTN Regulatory Affairs Specialist Senior (Abramson Cancer Center) (Remote Eligible)
- Philadelphia, PA (20 miles from Malvern, PA)
- 30+ days ago
- Philadelphia, PA (20 miles from Malvern, PA)
- 30+ days ago
The ACC is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. Contingent upon funding....
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Compliance Specialists in Malvern, PA 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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