Compliance Specialist Jobs in Massachusetts
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.
Nova Biomedical is hiring a Regulatory Affairs Specialist II to join our team in Waltham, MA. Regulatory Affairs Specialist II is a growth opportunity for individuals with some experience, who are...
Compliance Manager, Conflicts of Interest, Life Sciences
- Boston, MA
- 20 days ago
- Boston, MA
- 20 days ago
You are someone who thrives in a high-performance environment, bringing a growth mindset and entrepreneurial spirit to tackle meaningful challenges that have a real impact. In return for your...
Compliance Specialist, Conflicts of Interest, Life Sciences
- Boston, MA
- 22 days ago
- Boston, MA
- 22 days ago
You are someone who thrives in a high-performance environment, bringing a growth mindset and entrepreneurial spirit to tackle meaningful challenges that have a real impact. In return for your...
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...
The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as regulatory expert development and new...
Do you have a strong understanding of Sarbanes-Oxley (SOX) Compliance, including financial controls and IT general controls? Have you previously worked at Nasdaq-listed companies? If this sounds...
Regulatory Affairs Specialist II 3.1 3.1 out of 5 stars 180 Hartwell Road, Bedford, MA 01730 Overview: Position Summary: Responsible for domestic and/or international registration and renewal...
About Us We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity...
Who We Are: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising...
Compliance Specialist, Cell Therapy Manufacturing (Cambridge, MA)
- Cambridge, MA
- 60+ days ago
- Cambridge, MA
- 60+ days ago
Basic laboratory skills, including working with mammalian cell culture Experience working in an ISO 7 cleanroom environment....
Trials, etc., Advanced technical knowledge in global regulations and industry standards as they apply to clinical research, medical devices and pharmaceuticals and in the conduct of clinical study...
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Microsystems, one of Danahers 15+ operating...
Clinical Trial Regulatory Affairs Specialist (Boston, MA)
- Boston, MA
- 90+ days ago
- Boston, MA
- 90+ days ago
Knowledge: Strong understanding of clinical trial regulations, Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, and ethical standards....
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Compliance Specialists in Massachusetts offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Compliance Specialist position
- English
- Accounting
- Driving
- Financial Services
- Quality Systems
- ISO Certified
- Implementation
- Change Control
- ISO 13485
- Quality Management Systems
- Internal Audits
- GxP
- TrackWise
- 21 CFR 820
- ICH GCP
- Institutional Review Board
- Good Clinical Practice
- ICH Guidelines
- Medical Affairs
- Cell Culture
- Scientific Research
- Biology
- Biochemistry
- Microbiology
- Environmental Monitoring
- Biomedical Engineering
- Stem Cells
- Biotechnology
- Toxicology
- Clinical Trials
- Clinical Research
- Animal Care
- Medical Device Sales
- Corrective Actions & Preventive Actions
- FDA Regulations
- Good Manufacturing Practices
- Standard Operating Procedures
- Technical Writing
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Auditing
- Investigation
- Written Communication
- Education Experience
- Interpersonal Skills
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Policy Development
- Bachelor's Degree
- Regulations
- Microsoft Office
- Problem Solving
- Research Skills
- Microsoft Excel
- Organization
- Scheduling
- Leadership
- Communication Skills
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