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.
Stroke Compliance Coordinator Registered Nurse RN
- Richmond, VA
- 30+ days ago
- Richmond, VA
- 30+ days ago
Description Introduction Are you looking for a place to deliver excellent care patients deserve? At Johnston-Willis Hospital we support our colleagues in their positions. Join our Team as a(an)...
Required Qualifications Bachelors Degree ( 16 years), i n science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is...
Regulatory Affairs Specialist II Electrophysiology (on-site)
- Plymouth, MN
- 10 days ago
- Plymouth, MN
- 10 days ago
Preferred Qualifications Bachelors degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields. Masters degree in Regulatory Affairs....
Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)
- Alameda, CA
- 12 days ago
- Alameda, CA
- 12 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,...
Principal Regulatory Affairs Specialist US New Product Introduction Diabetes Care (on-site)
- Alameda, CA
- 45+ days ago
- Alameda, CA
- 45+ days ago
Chemistry, life Sciences, Biology (or equivalent vocational qualifications) Experienced in regulatory submissions for Pharmaceuticals, medical devices, and/or in vitro diagnostic devices....
Pharmaceutical Manufacturing company seeks a Regulatory Affairs Specialist. Resp. include ensuring compliance with FDA regulations, GMP and industry standards. Maintain and validate SOP to ensure...
Our mission is to make higher education accessible and affordable for everyone.** We empower students with financial support and supercharge their ability to pay down their debt, so they can get...
Remote WorkQA review and approval for deviations, CAPAs, change controls, PM Plans, Work Orders QA review and approval for master batch records (MBRs), SOPs, specifications, raw materials, executed batch...
review board....
Staff International Regulatory Affairs Specialist
- San Diego, CA
- 22 hours ago
- San Diego, CA
- 22 hours ago
Summary As Staff Regulatory Affairs Specialist, you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and Non-Medical Devices along with associated Software...
Job Description We are seeking a Quality Assurance Associate to support on-the-floor QA issues within the manufacturing suite. This role requires mitigating gaps and risks for all quality and GMP...
Temporary Regulatory Affairs Coordinator Job Description Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's...
trial authorization, licensing, lifecycle management; good knowledge of ICH and other global regulatory guidelines; basic understanding of a regulatory specialty areas, such as preclinical, clinical...
Sterility Assurance Lead - Contamination Control
- Pearl River, NY
- 23 hours ago
- Pearl River, NY
- 23 hours ago
Sterility Assurance Lead - Contamination Control Location: Pearl River, NY About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and...
Sr. Regulatory Affairs Specialist Grand River Aseptic Manufacturing life insurance, paid holidays, 401(k) United States, Michigan, Grand Rapids 140 Front Avenue Southwest (Show on map) Jun 12,...
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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
- Strategic Planning
- Verbal Communication
- Finance
- Mentoring
- Analytical Skills
- Environmental Compliance
- Quality Systems
- Water Quality
- Flexibility
- Air Quality
- Claims
- Change Control
- ISO 13485
- Quality Management Systems
- Environmental Education
- Batch Record Review
- Internal Audits
- GxP
- TrackWise
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- ICH Guidelines
- Good Clinical Practice
- Water Testing
- Drug Development
- Environmental Monitoring
- Biology
- Microbiology
- Biotechnology
- Clinical Trials
- Clinical Research
- Medical Device Sales
- Data Science
- Good Manufacturing Practices
- FDA Regulations
- Corrective Actions & Preventive Actions
- Machine Learning
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Risk Management
- Military Background
- Investigation
- Auditing
- Presentation
- Written Communication
- Collaboration
- Documentation
- Quality Assurance
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Policy Development
- Microsoft Office
- Problem Solving
- Sales
- Research Skills
- Microsoft Excel
- Teamwork
- Organization
- Scheduling
- Leadership
- Communication Skills
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