Quality Assurance Specialist Jobs in Waltham, 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.
SHE Compliance Manager Introduction to role Are you ready to take on a pivotal role in ensuring safety, health, and environmental compliance? As a SHE Compliance Manager, you'll be at the...
Compliance Manager, Conflicts of Interest, Life Sciences
- Boston, MA (10 miles from Waltham, MA)
- 11 days ago
- Boston, MA (10 miles from Waltham, MA)
- 11 days ago
You are someone who thrives in a high-performance environment, bringing a growth mindset and entrepreneurial spirit to tackle meaningful challenges that have a real impact. In return for your...
Compliance Specialist, Conflicts of Interest, Life Sciences
- Boston, MA (10 miles from Waltham, MA)
- 13 days ago
- Boston, MA (10 miles from Waltham, MA)
- 13 days ago
You are someone who thrives in a high-performance environment, bringing a growth mindset and entrepreneurial spirit to tackle meaningful challenges that have a real impact. In return for your...
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...
Senior Quality Assurance Associate
- Cambridge, MA (6 miles from Waltham, MA)
- 23 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 23 days ago
Senior Quality Assurance Associate Alnylam Pharmaceuticals United States, Massachusetts, Cambridge 675 West Kendall Street (Show on map) Jun 09, 2025 Overview The Senior Associate, Quality...
The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as regulatory expert development and new...
- Boston, MA (10 miles from Waltham, MA)
- 29 days ago
- Boston, MA (10 miles from Waltham, MA)
- 29 days ago
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
- Bedford, MA (7 miles from Waltham, MA)
- 30+ days ago
- Bedford, MA (7 miles from Waltham, MA)
- 30+ days ago
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...
Senior Regulatory Affairs Specialist
- Canton, MA (16 miles from Waltham, MA)
- 30+ days ago
- Canton, MA (16 miles from Waltham, MA)
- 30+ days ago
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...
- Devens, MA (20 miles from Waltham, MA)
- 30+ days ago
- Devens, MA (20 miles from Waltham, MA)
- 30+ days ago
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...
Compliance Specialist, Cell Therapy Manufacturing (Cambridge, MA)
- Cambridge, MA (6 miles from Waltham, MA)
- 60+ days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 60+ days ago
Basic laboratory skills, including working with mammalian cell culture Experience working in an ISO 7 cleanroom environment....
Senior GCP Quality & Compliance Auditor
- Boston, MA (10 miles from Waltham, MA)
- 60+ days ago
- Boston, MA (10 miles from Waltham, MA)
- 60+ days ago
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...
Regional Compliance Manager Americas
- Boston, MA (10 miles from Waltham, MA)
- 90+ days ago
- Boston, MA (10 miles from Waltham, 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? At Leica Microsystems, one of Danaher's 15+ operating...
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....
Demographic Data for Waltham, MA
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Salary for Quality Assurance Specialist Jobs in Waltham, MA
Highest Education Level
Quality Assurance Specialists in Waltham, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- English
- Driving
- Environmental Compliance
- Financial Services
- Quality Systems
- ISO Certified
- Geology
- Water Quality
- Implementation
- Air Quality
- Document Control
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Environmental Education
- Natural Resource Management
- Batch Record Review
- GxP
- TrackWise
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- ICH Guidelines
- Lab Safety
- Biology
- Drug Development
- Biochemistry
- Microbiology
- Environmental Monitoring
- Biotechnology
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Military Background
- Auditing
- Investigation
- Written Communication
- Interpersonal Skills
- Quality Assurance
- Collaboration
- Education Experience
- Documentation
- Reporting
- Bachelor's Degree
- Regulations
- Policy Development
- Microsoft Office
- Problem Solving
- Research Skills
- Microsoft Excel
- Organization
- Scheduling
- Leadership
- Communication Skills
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