Compliance Specialist Jobs in Waltham, 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.
Quality Compliance Manager (Partner)
- Billerica, MA (10 miles from Waltham, MA)
- 2 days ago
- Billerica, MA (10 miles from Waltham, MA)
- 2 days ago
Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has...
Legal Operations & Contract Compliance Specialist
- Boston, MA (10 miles from Waltham, MA)
- 5 days ago
- Boston, MA (10 miles from Waltham, MA)
- 5 days ago
The team is looking for an energetic, creative, talented and experienced Legal Ops & Contract Compliance Specialist with a passion for managing contracts in a high-volume, fast-paced, high-performing...
Remote WorkCompliance Specialist, Cell Therapy Manufacturing
- Cambridge, MA (6 miles from Waltham, MA)
- 5 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 5 days ago
Basic laboratory skills, including working with mammalian cell culture Experience working in an ISO 7 cleanroom environment. Why Vericel?...
Principal Regulatory Affairs Specialist Pathai
- Boston, MA (10 miles from Waltham, MA)
- 7 days ago
- Boston, MA (10 miles from Waltham, MA)
- 7 days ago
Who We ArePathAI is on a mission to improve patient outcomes with AI-powered pathology.We are transforming traditional pathology methods into powerful, new technologies.These innovations in...
guidelines Pay and Benefits The pay range for this position is $25.00 - $27.00/hr....
- Tewksbury, MA (14 miles from Waltham, MA)
- 16 days ago
- Tewksbury, MA (14 miles from Waltham, MA)
- 16 days ago
Cambridge Isotope Laboratories, Inc. (CIL) is searching for a Quality Assurance Associate I based onsite in our Tewksbury, MA facility. CIL is the global leading company in a highly technical,...
- Westborough, MA (20 miles from Waltham, MA)
- 23 days ago
- Westborough, MA (20 miles from Waltham, MA)
- 23 days ago
Job Description: Compliance Specialist CMC Do you want to be part of an inclusive team that works to develop innovative therapies for patients?...
Senior GCP Quality & Compliance Auditor
- Boston, MA (10 miles from Waltham, MA)
- 23 days ago
- Boston, MA (10 miles from Waltham, MA)
- 23 days ago
As a technical expert in quality and compliance, the Senior Quality & Compliance Auditor plays a critical role in ensuring adherence to company policies, study protocols, GxP guidelines, and...
Regulatory Affairs Specialist, Biologics
- Tewksbury, MA (14 miles from Waltham, MA)
- 30+ days ago
- Tewksbury, MA (14 miles from Waltham, MA)
- 30+ days ago
Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough...
Regional Compliance Manager Americas
- Boston, MA (10 miles from Waltham, MA)
- 30+ days ago
- Boston, MA (10 miles from Waltham, MA)
- 30+ days ago
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 Danaher's 15+ operating...
QA Principal Compliance Specialist, Operations
- Framingham, MA (10 miles from Waltham, MA)
- 90+ days ago
- Framingham, MA (10 miles from Waltham, MA)
- 90+ days ago
The Principal Compliance Specialist may also be responsible for providing leadership to the QA team in the absence of the manager....
Quality Systems & Regulatory Affairs Specialist, Digital Health
- Boston, MA (10 miles from Waltham, MA)
- 45+ days ago
- Boston, MA (10 miles from Waltham, MA)
- 45+ days ago
At WHOOP, we're on a mission to unlock human performance and health span. WHOOP empowers its members to perform at a higher level through a deep understanding of their bodies and daily lives....
Clinical Trial Regulatory Affairs Specialist (Boston, MA)
- Boston, MA (10 miles from Waltham, MA)
- 90+ days ago
- Boston, MA (10 miles from Waltham, MA)
- 90+ days ago
Knowledge: Strong understanding of clinical trial regulations, Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, and ethical standards....
Inventory Control and SOX Compliance Manager
- Billerica, MA (10 miles from Waltham, MA)
- 90+ days ago
- Billerica, MA (10 miles from Waltham, MA)
- 90+ days ago
Lantheus is headquartered in Bedford, Massachusetts with offices in Canada and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has...
Demographic Data for Waltham, MA
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Salary for Compliance Specialist Jobs in Waltham, MA
Highest Education Level
Compliance Specialists in Waltham, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Compliance Specialist position
- Environmental Compliance
- Waste Management
- Environmental Management
- Quality Systems
- ISO Certified
- Water Quality
- Implementation
- Air Quality
- Inspections
- ISO 13485
- Environmental Education
- Natural Resource Management
- ISO 14001
- Certified Hazardous Materials Manager
- GxP
- ASQ Certified Quality Auditor
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Clinical Data Management
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Field Sampling
- Environmental Monitoring
- Biology
- Biotechnology
- Clinical Trials
- Good Laboratory Practice
- Environmental Science
- Clinical Research
- Genetics
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Machine Learning
- Engineering
- Strategy Development
- Process Improvement
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Sales
- Policy Development
- Project Management
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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