Compliance Specialist Jobs in Indiana
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 Quality Control Compliance Specialist plays a vital role on the QC team with analytical and microbiological testing experience....
Description: The QA Compliance Specialist implements robust Quality Systems for us considering regulatory requirements of the organization....
Overview The Regulatory Affairs Specialist II has primary responsibility for provision of In Vitro Diagnostic regulatory support to prepare, execute and maintain regulatory filings including...
Quality Assurance Associate - Drug Product External Manufacturing
- Indianapolis, IN
- 90+ days ago
- Indianapolis, IN
- 90+ days ago
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world...
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Salary for Compliance Specialist Jobs in Indiana
Required or preferred licenses and certifications for Compliance Specialist positions.
Highest Education Level
Compliance Specialists in Indiana 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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