Quality Assurance Specialist Jobs in Woburn, MA
A Quality Assurance (QA) Specialist in the biotechnology industry is responsible for ensuring that the biomedical products, pharmaceuticals, and medical devices produced meet strict quality standards. They conduct routine audits, develop quality control procedures, and oversee the manufacturing process to ensure compliance with legal regulations and industry standards. QA Specialists also assist in problem-solving efforts relating to quality management and perform regular inspections, documenting any discrepancies and implementing corrective actions when necessary.
A strong candidate for a QA Specialist typically requires a bachelor's degree in biology, chemistry, or a related field. They should have excellent attention to detail, strong communication skills, and the ability to work in a regulated environment. A working knowledge of FDA regulations, ISO standards, and GMP (Good Manufacturing Practices) is often required. Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Certified Quality Improvement Associate (CQIA) are relevant certifications. Prior to becoming a QA Specialist, a person might have roles such as a Lab Technician, Quality Control Analyst, or Research Associate in the biotechnology field.
Animal Welfare Program Compliance Specialist
- Charles River Laboratories
- Cambridge, MA (7 miles from Woburn, MA)
- 1 hour ago
- Cambridge, MA (7 miles from Woburn, MA)
- 1 hour ago
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant...
Hybrid- TetraScience
- Cambridge, MA (7 miles from Woburn, MA)
- 4 days ago
- Cambridge, MA (7 miles from Woburn, MA)
- 4 days ago
About TetraScience TetraScience is the Scientific Data and AI Company building Tetra OS, the operating system for scientific intelligence. We help the world's leading life sciences firms turn...
In Person- Quanterix Corporation
- Billerica, MA (6 miles from Woburn, MA)
- 12 days ago
- Billerica, MA (6 miles from Woburn, MA)
- 12 days ago
In 2025, Quanterix acquired Akoya Biosciences, The Spatial Biology Company, adding multiplexed tissue imaging with single-cell resolution to its portfolio....
In PersonCompliance Manager COMPL003861
- Lantheus
- North Billerica, MA (8 miles from Woburn, MA)
- 13 days ago
- North Billerica, MA (8 miles from Woburn, MA)
- 13 days ago
About Lantheus Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better...
In Person- Lantheus
- N Billerica, MA (8 miles from Woburn, MA)
- 27 days ago
- N Billerica, MA (8 miles from Woburn, MA)
- 27 days ago
About Lantheus Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better...
In Person- Lantheus
- Bedford, MA (5 miles from Woburn, MA)
- 30+ days ago
- Bedford, MA (5 miles from Woburn, MA)
- 30+ days ago
About Lantheus Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better...
In Person- Danaher Corporation
- Marlborough, MA (22 miles from Woburn, MA)
- 90+ days ago
- Marlborough, MA (22 miles from Woburn, MA)
- 90+ days ago
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? Within Danaher the work our life science businesses...
In Person- MIT
- Cambridge, MA (7 miles from Woburn, MA)
- 90+ days ago
- Cambridge, MA (7 miles from Woburn, MA)
- 90+ days ago
COMPLIANCE SPECIALIST 1, Vice President for Research, to ensure compliance with federal, state, and local policies, and guidelines related to research protocols involving human subjects at MIT on...
In PersonDemographic Data for Woburn, MA
Moving to Woburn, MA? Find some basic demographic data about Woburn, MA below.
Quality Assurance Specialist Online Courses and Training Opportunities
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Salary for Quality Assurance Specialist Jobs in Woburn, MA
Highest Education Level
Quality Assurance Specialists in Woburn, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Environmental Compliance
- Environmental Planning
- Water Quality
- Inspections
- ISO 13485
- Clean Water Act
- National Pollutant Discharge Elimination System
- Batch Record Review
- GxP
- 21 CFR 820
- Molecular Biology
- Good Clinical Practice
- ICH Guidelines
- Institutional Review Board
- ICH GCP
- Biomedical Engineering
- Lab Safety
- Genomics
- Gene Therapy
- Biochemistry
- Environmental Monitoring
- Microbiology
- Biology
- Good Laboratory Practice
- Ecology
- Environmental Science
- Clinical Trials
- Clinical Research
- Biotechnology
- Laboratory Management
- Medical Device Sales
- FDA Regulations
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Diagnostic
- Technical Writing
- Strategy Development
- Engineering
- Quality Control
- Military Background
- Auditing
- Written Communication
- Investigation
- Quality Assurance
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Collaboration
- Education Experience
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Excel
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Leadership
- Communication Skills
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