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.
Research Regulatory Compliance Specialist
- Brookline, MA (8 miles from Waltham, MA)
- 5 days ago
- Brookline, MA (8 miles from Waltham, MA)
- 5 days ago
Delivers education to study staff on various topics including good clinical practice, research regulations and the conduct of clinical trials....
Research Regulatory Compliance Specialist Boston Children's Hospital
- Brookline, MA (8 miles from Waltham, MA)
- 6 days ago
- Brookline, MA (8 miles from Waltham, MA)
- 6 days ago
Delivers education to study staff on various topics including good clinical practice, research regulations and the conduct of clinical trials....
Research Regulatory Compliance Specialist
- Boston, MA (10 miles from Waltham, MA)
- 7 days ago
- Boston, MA (10 miles from Waltham, MA)
- 7 days ago
Delivers education to study staff on various topics including good clinical practice, research regulations and the conduct of clinical trials....
Quality Assurance Associate Director, CMO Management (Cell and Genetic Programs)
- Boston, MA (10 miles from Waltham, MA)
- 7 days ago
- Boston, MA (10 miles from Waltham, MA)
- 7 days ago
Job Description General/Position Summary The Associate Director, Quality Assurance is responsible for supporting the day-to-day Quality Operations of Contract Manufacturing Organizations (CMOs)...
- Westborough, MA (20 miles from Waltham, MA)
- 8 days ago
- Westborough, MA (20 miles from Waltham, MA)
- 8 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)
- 8 days ago
- Boston, MA (10 miles from Waltham, MA)
- 8 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)
- 18 days ago
- Tewksbury, MA (14 miles from Waltham, MA)
- 18 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)
- 21 days ago
- Boston, MA (10 miles from Waltham, MA)
- 21 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...
Quality Systems & Regulatory Affairs Specialist, Digital Health
- Boston, MA (10 miles from Waltham, MA)
- 30+ days ago
- Boston, MA (10 miles from Waltham, MA)
- 30+ 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....
- Cambridge, MA (6 miles from Waltham, MA)
- 30+ days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 30+ days ago
Quality Compliance Specialist Job Description Job Title: Clinical Quality Compliance Lead Duration: 12 Months Location: Cambridge, MA (02142) - Hybrid role, 2 days per week on-site Objectives/Purpose...
QA Senior Compliance Specialist, Night Time Operations
- Framingham, MA (10 miles from Waltham, MA)
- 45+ days ago
- Framingham, MA (10 miles from Waltham, MA)
- 45+ days ago
Job Title: QA Senior Compliance Specialist, Night Time Operations Location: Framingham, MA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning...
SSGA Compliance Analyst, Assistant Vice President, Hybrid
- Boston, MA (10 miles from Waltham, MA)
- 45+ days ago
- Boston, MA (10 miles from Waltham, MA)
- 45+ days ago
Who we are looking for The SSGA Compliance team is looking to hire a Compliance Analyst, Assistant Vice President, to join the SSGA North America Compliance team. State Street Global Advisors...
- Boston, MA (10 miles from Waltham, MA)
- 60+ days ago
- Boston, MA (10 miles from Waltham, MA)
- 60+ days ago
DCAMM’S Mission The Division of Capital Asset Management and Maintenance (DCAMM) oversees over $2 billion in capital programs and projects, and is responsible for capital planning, project...
Clinical Trial Regulatory Affairs Specialist (Boston, MA)
- Boston, MA (10 miles from Waltham, MA)
- 60+ days ago
- Boston, MA (10 miles from Waltham, MA)
- 60+ 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)
- 60+ days ago
- Billerica, MA (10 miles from Waltham, MA)
- 60+ 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...
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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
- Verbal Communication
- Filing
- Environmental Compliance
- NEPA
- CERCLA
- Environmental Management
- Quality Systems
- ISO Certified
- Implementation
- Air Quality
- Inspections
- ISO 13485
- Clean Water Act
- Environmental Education
- Clean Air Act
- Natural Resource Management
- ISO 14001
- Certified Hazardous Materials Manager
- Reimbursement
- GxP
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Clinical Data Management
- Good Clinical Practice
- Gene Therapy
- ICH Guidelines
- Field Sampling
- Biology
- Ecology
- Pharmacovigilance
- Good Laboratory Practice
- Biotechnology
- Clinical Trials
- Clinical Research
- Environmental Science
- Genetics
- FDA Regulations
- Medical Device Sales
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Microsoft PowerPoint
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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