Quality Assurance Specialist Jobs in Boston, 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.
Compliance Specialist - Conflicts of Interest, Life Sciences
- Boston, MA
- 3 days ago
- Boston, MA
- 3 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...
- Cambridge, MA (3 miles from Boston, MA)
- 12 days ago
- Cambridge, MA (3 miles from Boston, MA)
- 12 days ago
USA - Compliance Analyst#25-67892 Cambridge, MA All On-site Job Description Actual Job title: Associate Director, PSPV Compliance & Analytics Objective / Purpose: The Associate director, PSPV...
Remote WorkAbout the Job The Director, Compliance Officer is a member of the Legal and Compliance Department and is responsible for partnering with the business to implement the Business Ethics and...
We are seeking an experienced IT Infrastructure & Compliance Specialist to support enterprise-scale vulnerability remediation, OS upgrade projects, and infrastructure compliance across lab and...
USA-Quality Assurance Associate II (Scientific)
- Cambridge, MA (3 miles from Boston, MA)
- 22 days ago
- Cambridge, MA (3 miles from Boston, MA)
- 22 days ago
Coordinate with dossier management group and biology leads to ensure study report conforms with the prescribed formatting requirements. 3....
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services...
Regulatory Affairs Specialist II
- Waltham, MA (10 miles from Boston, MA)
- 45+ days ago
- Waltham, MA (10 miles from Boston, MA)
- 45+ days ago
Nova Biomedical is hiring a Regulatory Affairs Specialist II to join our team in Waltham, MA. Regulatory Affairs Specialist II is a growth opportunity for individuals with some experience, who are...
- Waltham, MA (10 miles from Boston, MA)
- 60+ days ago
- Waltham, MA (10 miles from Boston, MA)
- 60+ days ago
guidelines Pay and Benefits The pay range for this position is $25.00 - $27.00/hr....
Senior Regulatory Affairs Specialist
- Canton, MA (12 miles from Boston, MA)
- 60+ days ago
- Canton, MA (12 miles from Boston, MA)
- 60+ 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...
Compliance Specialist, Cell Therapy Manufacturing (Cambridge, MA)
- Cambridge, MA (3 miles from Boston, MA)
- 90+ days ago
- Cambridge, MA (3 miles from Boston, MA)
- 90+ days ago
The Compliance Specialist provides support for projects, manufacturing execution, computer systems (GP, EBR, OpCenter APS), quality systems (deviations, change controls, CAPAs) and implementation...
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 Boston, MA
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Required or preferred licenses and certifications for Quality Assurance Specialist positions.
Highest Education Level
Quality Assurance Specialists in Boston, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Continuous Improvement
- Filing
- Quality Systems
- ISO Certified
- Water Quality
- Implementation
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Clean Water Act
- Batch Record Review
- GxP
- TrackWise
- 21 CFR 820
- ICH GCP
- Institutional Review Board
- Genomics
- ICH Guidelines
- Gene Therapy
- Lab Safety
- Good Clinical Practice
- Medical Affairs
- Biology
- Ecology
- Microbiology
- Pharmacovigilance
- Environmental Monitoring
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Analytical Chemistry
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Good Manufacturing Practices
- FDA Regulations
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Diagnostic
- Technical Writing
- Engineering
- Strategy Development
- Risk Management
- Quality Control
- Auditing
- Written Communication
- Documentation
- Investigation
- Collaboration
- Reporting
- Quality Assurance
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Regulations
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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