Quality Assurance Specialist Jobs in New Haven, CT
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.
trials, operations, and ICH Good Clinical Practices, federal regulations, and institutional processes....
Senior Research Compliance Specialist, Reliance
- Orange, CT (5 miles from New Haven, CT)
- 5 days ago
- Orange, CT (5 miles from New Haven, CT)
- 5 days ago
Work Location Orange, California Work Shift Day - 08hrs (United States of America) Why CHOC? At CHOC, we strive to be the leading destination of children's health by providing exceptional and...
Quality Assurance Associate III - Supplier Quality
- Milford, CT (9 miles from New Haven, CT)
- 9 days ago
- Milford, CT (9 miles from New Haven, CT)
- 9 days ago
Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA,...
External Quality Assurance Associate III
- Milford, CT (9 miles from New Haven, CT)
- 20 days ago
- Milford, CT (9 miles from New Haven, CT)
- 20 days ago
Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA,...
- Trumbull, CT (14 miles from New Haven, CT)
- 30+ days ago
- Trumbull, CT (14 miles from New Haven, CT)
- 30+ days ago
., Life Sciences, Biology, Chemistry, Engineering, Regulatory Science). Certificates, Licenses, Registrations. 3+ years Medical Device Regulatory experience....
- Trumbull, CT (14 miles from New Haven, CT)
- 45+ days ago
- Trumbull, CT (14 miles from New Haven, CT)
- 45+ days ago
Bachelors degree in chemistry, biochemistry, biology, library science, or related field preferred. Minimum of one year of regulatory experience, preferably in Consumer Packaged Goods....
Position Focus: Coordinate and conduct research billing reviews for all randomly selected clinical trials with billable services based on risk....
Demographic Data for New Haven, CT
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Salary for Quality Assurance Specialist Jobs in New Haven, CT
Required or preferred licenses and certifications for Quality Assurance Specialist positions.
Highest Education Level
Quality Assurance Specialists in New Haven, CT offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Consulting
- Decision Making
- Environmental Compliance
- Environmental Management
- Quality Systems
- ISO Certified
- Treasury
- Implementation
- Securities and Exchange Commission
- Balance Sheets
- Treasury Management
- Inspections
- ISO 13485
- Quality Management Systems
- Environmental Education
- Capital Markets
- Anti-Money Laundering
- Management Consulting
- ISO 14001
- Certified Hazardous Materials Manager
- HACCP Certified
- GxP
- Supplier Auditing
- Comprehensive Capital Analysis and Review
- 21 CFR 820
- Institutional Review Board
- ICH Guidelines
- Environmental Monitoring
- Biology
- Clinical Trials
- Biotechnology
- Environmental Science
- Genetics
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Engineering
- Affirmative Action
- Strategy Development
- Risk Management
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Microsoft PowerPoint
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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