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.
QA review and approval for deviations, CAPAs, change controls, PM Plans, Work Orders QA review and approval for master batch records (MBRs), SOPs, specifications, raw materials, executed batch...
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...
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...
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...
Trials strategies to enable clinical trial functional areas and study teams to embed inspection readiness and process adherence into ways of working....
Remote WorkRWD Compliance Manager Company: Norstella Location: Remote, United States Date Posted: May 23, 2025 Employment Type: Full Time Job ID: R-1204 **Description** **About Norstella:** At Norstella, our...
Senior Corporate Compliance Manager - Training, Communications & Policy (Remote)
- Boston, MA
- 23 days ago
- Boston, MA
- 23 days ago
California, US residents click here (. **The job details are as follows:** Who we are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit...
that regulatory requirements are met for clinical trials....
Remote WorkRegulatory Compliance Manager Dana-Farber Cancer Institute
- Brookline, MA
- 30+ days ago
- Brookline, MA
- 30+ days ago
The Regulatory Compliance Manager at Dana-Farber is responsible for coordinating and leading regulatory compliance activities across all sites. This role is crucial in managing Dana-Farber?s...
Overview The Regulatory Compliance Manager at Dana-Farber is responsible for coordinating and leading regulatory compliance activities across all sites. This role is crucial in managing...
Compliance Specialist, Cell Therapy Manufacturing (Cambridge, MA)
- Cambridge, MA
- 45+ days ago
- Cambridge, MA
- 45+ 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...
Demographic Data for Massachusetts
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Highest Education Level
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
- Strategic Planning
- Verbal Communication
- Finance
- Mentoring
- Analytical Skills
- Environmental Compliance
- Quality Systems
- Water Quality
- Flexibility
- Air Quality
- Claims
- Change Control
- ISO 13485
- Quality Management Systems
- Environmental Education
- Batch Record Review
- Internal Audits
- GxP
- TrackWise
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- ICH Guidelines
- Good Clinical Practice
- Water Testing
- Drug Development
- Environmental Monitoring
- Biology
- Microbiology
- Biotechnology
- Clinical Trials
- Clinical Research
- Medical Device Sales
- Data Science
- Good Manufacturing Practices
- FDA Regulations
- Corrective Actions & Preventive Actions
- Machine Learning
- Standard Operating Procedures
- Masters In Education
- Engineering
- Strategy Development
- Risk Management
- Military Background
- Investigation
- Auditing
- Presentation
- Written Communication
- Collaboration
- Documentation
- Quality Assurance
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Policy Development
- Microsoft Office
- Problem Solving
- Sales
- Research Skills
- Microsoft Excel
- Teamwork
- Organization
- Scheduling
- Leadership
- Communication Skills
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