Compliance Specialist Jobs in Cambridge, MA
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.
- Boston, MA (3 miles from Cambridge, MA)
- 6 days ago
- Boston, MA (3 miles from Cambridge, MA)
- 6 days ago
Deliverables expected: Regulatory Compliance Ensure all clinical trials meet FDA, EMA, and ICH standards....
Remote WorkUSA - Compliance Analyst#25-67892 Cambridge, MA All On-site Job Description Actual Job title: Associate Director, PSPV Compliance & Analytics Objective / Purpose: The Associate director, PSPV...
Remote Work- Boston, MA (3 miles from Cambridge, MA)
- 6 days ago
- Boston, MA (3 miles from Cambridge, MA)
- 6 days ago
About the Job The Director, Compliance Officer is a member of the Legal and Compliance Department and is responsible for partnering with the business to implement the Business Ethics and...
IT Infrastructure & Compliance Specialist
- Boston, MA (3 miles from Cambridge, MA)
- 13 days ago
- Boston, MA (3 miles from Cambridge, MA)
- 13 days ago
We are seeking an experienced IT Infrastructure & Compliance Specialist to support enterprise-scale vulnerability remediation, OS upgrade projects, and infrastructure compliance across lab and manufacturing...
Coordinate with dossier management group and biology leads to ensure study report conforms with the prescribed formatting requirements. 3....
Senior U.S. Compliance Manager
- Boston, MA (3 miles from Cambridge, MA)
- 20 days ago
- Boston, MA (3 miles from Cambridge, MA)
- 20 days ago
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services...
Regulatory Affairs Specialist II
- Waltham, MA (6 miles from Cambridge, MA)
- 30+ days ago
- Waltham, MA (6 miles from Cambridge, MA)
- 30+ days ago
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...
- Waltham, MA (6 miles from Cambridge, MA)
- 60+ days ago
- Waltham, MA (6 miles from Cambridge, MA)
- 60+ days ago
guidelines Pay and Benefits The pay range for this position is $25.00 - $27.00/hr....
Senior Regulatory Affairs Specialist
- Canton, MA (13 miles from Cambridge, MA)
- 60+ days ago
- Canton, MA (13 miles from Cambridge, MA)
- 60+ days ago
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...
Compliance Specialist, Cell Therapy Manufacturing (Cambridge, MA)
- Cambridge, MA
- 90+ days ago
- Cambridge, MA
- 90+ days ago
The Compliance Specialist provides support for projects, manufacturing execution, computer systems (GP, EBR, OpCenter APS), quality systems (deviations, change controls, CAPAs) and implementation of...
Senior GCP Quality & Compliance Auditor
- Boston, MA (3 miles from Cambridge, MA)
- 90+ days ago
- Boston, MA (3 miles from Cambridge, MA)
- 90+ days ago
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...
Demographic Data for Cambridge, MA
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Compliance Specialists in Cambridge, MA 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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