Quality Assurance Specialist Jobs in New York
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.
Reporting directly to the Chief Compliance Officer, Oncology, the Head of US Compliance and Deputy CCO leads US Compliance program and serves as the primary strategic partner to US business. This...
In PersonResearch Compliance Specialist II
- Rochester Institute of Technology
- Rochester, NY
- 3 days ago
- Rochester, NY
- 3 days ago
Research Compliance Specialist II Essential Duties & Responsibilities Ensures research activities comply with RIT policies and procedures, federal regulations, and state and local laws relative to...
In PersonHead of US Compliance and Deputy Chief Compliance Officer
- Menarini Group
- New York, NY
- 5 days ago
- New York, NY
- 5 days ago
Overview Head of US Compliance and Deputy Chief Compliance Officer (Executive Director) Reports to Chief Compliance Officer, Oncology Founded in 1886 in Naples under the name of Farmacia...
In PersonSenior Administrative Assistant, Compliance Coordinator - IRB & COI
- Binghamton University
- Binghamton, NY
- 30+ days ago
- Binghamton, NY
- 30+ days ago
Senior Administrative Assistant, Compliance Coordinator - IRB & COI Office for the Protection of HumanSubjects Division of Research Binghamton University The ComplianceCoordinator - IRB & COI...
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Salary for Quality Assurance Specialist Jobs in New York
Highest Education Level
Quality Assurance Specialists in New York offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Filing
- 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
- Cancer Research
- 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
- Auditing
- Written Communication
- Investigation
- Quality Assurance
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Collaboration
- Education Experience
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Excel
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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