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.
Compliance Manager, Conflicts of Interest, Life Sciences
- New York City, NY
- 6 days ago
- New York City, NY
- 6 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
- New York City, NY
- 8 days ago
- New York City, NY
- 8 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...
Sterility Assurance Lead - Contamination Control
- Pearl River, NY
- 17 days ago
- Pearl River, NY
- 17 days ago
Sterility Assurance Lead - Contamination Control Location: Pearl River, NY About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and...
Jr. Product Development and Compliance Specialist New York, New York Who We Ar e SiriusPoint is a global underwriter of insurance and reinsurance. We utilize deep risk capabilities to protect our...
Regulatory Compliance Coordinator I - Cardiology
- Pavilion, NY
- 45+ days ago
- Pavilion, NY
- 45+ days ago
Description The Regulatory Compliance Coordinator I works with investigators, consortiums, and the Clinical Trials Office infrastructure to develop new clinical trials....
Quality Compliance Manager (Saranac Lake, NY)
- Saranac Lake, NY
- 60+ days ago
- Saranac Lake, NY
- 60+ days ago
requested Possesses working knowledge of regulatory environment and industry standards Coordinates test record review Requirements: Bachelors degree from an accredited college/university in microbiology, biology...
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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
- English
- Driving
- Environmental Compliance
- Quality Systems
- ISO Certified
- Geology
- Implementation
- Air Quality
- Document Control
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Environmental Education
- Batch Record Review
- GxP
- TrackWise
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- ICH Guidelines
- Good Clinical Practice
- Lab Safety
- Drug Development
- Biology
- Environmental Monitoring
- Microbiology
- Biotechnology
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Data Science
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Machine Learning
- Engineering
- Risk Management
- Military Background
- Auditing
- Investigation
- Written Communication
- Interpersonal Skills
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Policy Development
- Microsoft Office
- Problem Solving
- Sales
- Research Skills
- Organization
- Scheduling
- Leadership
- Communication Skills
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