Compliance Specialist Jobs in Lexington, 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.
- Waltham, MA (4 miles from Lexington, MA)
- 4 days ago
- Waltham, MA (4 miles from Lexington, MA)
- 4 days ago
guidelines Work Environment You will work with a team of 3-4 individuals in a 1st shift Monday to Friday business casual environment....
- Cambridge, MA (6 miles from Lexington, MA)
- 5 days ago
- Cambridge, MA (6 miles from Lexington, MA)
- 5 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...
Regulatory Affairs Specialist/Senior RA Specialist (East Coast preferred)
- Boston, MA (10 miles from Lexington, MA)
- 5 days ago
- Boston, MA (10 miles from Lexington, MA)
- 5 days ago
What you will need Bachelor's degree in a technical discipline, such as Engineering, Bio-Medical Engineering, Computer Science, Biology, Chemistry or related field....
- Billerica, MA (6 miles from Lexington, MA)
- 5 days ago
- Billerica, MA (6 miles from Lexington, MA)
- 5 days ago
Director of QualityJob Description Help support and oversee the quality group, with a focus on compliance and auditing to ensure alignment with pharmaceutical and medical device regulations. Work...
Customer Compliance Specialist
- Needham, MA (12 miles from Lexington, MA)
- 6 days ago
- Needham, MA (12 miles from Lexington, MA)
- 6 days ago
At Encore Fire Protection, we're searching for a driven and enthusiastic Customer Compliance Specialist to join our dynamic team....
Regulatory Affairs Specialist, Biologics
- Tewksbury, MA (10 miles from Lexington, MA)
- 7 days ago
- Tewksbury, MA (10 miles from Lexington, MA)
- 7 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...
- Boston, MA (10 miles from Lexington, MA)
- 10 days ago
- Boston, MA (10 miles from Lexington, MA)
- 10 days ago
Job Description General Summary: The Compliance Manager leads efforts to establish and maintain a third-party certification (SOC 2) for Vertex. This role maintains and evolves DTEs controls...
Finance Risk Compliance - Consultant/Manager
- Boston, MA (10 miles from Lexington, MA)
- 12 days ago
- Boston, MA (10 miles from Lexington, MA)
- 12 days ago
Job Description In Strategy & Consulting we work with C-suite executives, leaders and boards of the world's leading organizations, helping them reinvent every part of their enterprise to drive...
QA Senior Compliance Specialist, Night Time Operations
- Framingham, MA (14 miles from Lexington, MA)
- 12 days ago
- Framingham, MA (14 miles from Lexington, MA)
- 12 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...
Laboratory Quality and Compliance Coordinator
- Boston, MA (10 miles from Lexington, MA)
- 21 days ago
- Boston, MA (10 miles from Lexington, MA)
- 21 days ago
, Biochemistry)....
QA Senior Compliance Specialist, Operations
- Framingham, MA (14 miles from Lexington, MA)
- 22 days ago
- Framingham, MA (14 miles from Lexington, MA)
- 22 days ago
Job title : QA Senior Compliance Specialist, Operations Location : Framingham, MA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and...
SSGA Compliance Analyst, Assistant Vice President, Hybrid
- Boston, MA (10 miles from Lexington, MA)
- 22 days ago
- Boston, MA (10 miles from Lexington, MA)
- 22 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...
Compliance Specialist (Saturday-Wednesday)
- Boston, MA (10 miles from Lexington, MA)
- 30+ days ago
- Boston, MA (10 miles from Lexington, MA)
- 30+ days ago
As a Compliance Specialist you will drive adherence to internal and external policies such as Klaviyo's Acceptable Use Policy (AUP) through both technology and one-on-one customer engagements....
Regulatory Affairs Specialist III
- Boston, MA (10 miles from Lexington, MA)
- 30+ days ago
- Boston, MA (10 miles from Lexington, MA)
- 30+ days ago
REQUIREMENTS: MINIMUM Education Requirement: Bachelor's degree in Regulatory Science, Biology, Chemistry, Bio-Engineering, or related field of study....
Remote Work- Bedford, MA (4 miles from Lexington, MA)
- 30+ days ago
- Bedford, MA (4 miles from Lexington, MA)
- 30+ days ago
Regulatory Affairs Specialist Responsibilities: Determine and document change assessments for US Class II devices to ensure compliance with the US regulation. Plan and prepare submissions for US...
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Compliance Specialists in Lexington, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Compliance Specialist position
- Consulting
- Decision Making
- Environmental Compliance
- Environmental Management
- Quality Systems
- ISO Certified
- Treasury
- Implementation
- Securities and Exchange Commission
- Balance Sheets
- Treasury Management
- Inspections
- ISO 13485
- Quality Management Systems
- Environmental Education
- Capital Markets
- Anti-Money Laundering
- Management Consulting
- ISO 14001
- Certified Hazardous Materials Manager
- HACCP Certified
- GxP
- Supplier Auditing
- Comprehensive Capital Analysis and Review
- 21 CFR 820
- Institutional Review Board
- ICH Guidelines
- Environmental Monitoring
- Biology
- Clinical Trials
- Biotechnology
- Environmental Science
- Genetics
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Engineering
- Affirmative Action
- Strategy Development
- Risk Management
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Microsoft PowerPoint
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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