Quality Assurance Specialist Jobs in Massachusetts
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.
Delivers education to study staff on various topics including good clinical practice, research regulations and the conduct of clinical trials....
Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has...
Who we are:** Rubrik is one of the fastest growing companies in Silicon Valley, revolutionizing data protection and management in the emerging multi-cloud IT industry. Recently a Top 10 of the...
Remote WorkCompliance Specialist, Cell Therapy Manufacturing
- Cambridge, MA
- 12 days ago
- Cambridge, MA
- 12 days ago
Basic laboratory skills, including working with mammalian cell culture Experience working in an ISO 7 cleanroom environment. Why Vericel?...
Who We ArePathAI is on a mission to improve patient outcomes with AI-powered pathology.We are transforming traditional pathology methods into powerful, new technologies.These innovations in...
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...
Cambridge Isotope Laboratories, Inc. (CIL) is searching for a Quality Assurance Associate I based onsite in our Tewksbury, MA facility. CIL is the global leading company in a highly technical,...
Job Description: Compliance Specialist CMC Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver...
As a technical expert in quality and compliance, the Senior Quality & Compliance Auditor plays a critical role in ensuring adherence to company policies, study protocols, GxP guidelines, and...
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...
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...
DCAMM’S Mission The Division of Capital Asset Management and Maintenance (DCAMM) oversees over $2 billion in capital programs and projects, and is responsible for capital planning, project...
Clinical Trial Regulatory Affairs Specialist (Boston, MA)
- Boston, MA
- 90+ days ago
- Boston, MA
- 90+ days ago
Knowledge: Strong understanding of clinical trial regulations, Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, and ethical standards....
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Highest Education Level
Quality Assurance Specialists in Massachusetts 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
- Quality Systems
- Geology
- Water Quality
- Implementation
- Air Quality
- Inspections
- ISO 13485
- Environmental Education
- Natural Resource Management
- Batch Record Review
- GxP
- ASQ Certified Quality Auditor
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Clinical Data Management
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Mammalian Cell Culture
- Field Sampling
- Environmental Monitoring
- Biology
- Biochemistry
- Pharmacovigilance
- Microbiology
- Clinical Trials
- Biotechnology
- Good Laboratory Practice
- Clinical Research
- Genetics
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Machine Learning
- Engineering
- Strategy Development
- Process Improvement
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Sales
- Policy Development
- Project Management
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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