Quality Assurance Specialist Jobs in Chicago, IL
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 applications; and, + IT working knowledge in a biotech research lab environment, familiar with lab systems implementation and system requirements, clinical operations + Knowledge of systems...
Compliance Specialist - Conflicts of Interest, Life Sciences
- Chicago, IL
- 3 days ago
- Chicago, IL
- 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...
Laboratory Accreditation - PT Compliance Specialist
- Northfield, IL (14 miles from Chicago, IL)
- 5 days ago
- Northfield, IL (14 miles from Chicago, IL)
- 5 days ago
Who we are? As the world's largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American...
at Miltenyi Biotec, Inc. in Chicago, Illinois, United States Job Description Description Your Role: The Healthcare Compliance Officer will serve as the lead compliance authority for the US...
Ann & Robert H. Lurie Childrens Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and...
Demographic Data for Chicago, IL
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Salary for Quality Assurance Specialist Jobs in Chicago, IL
Required or preferred licenses and certifications for Quality Assurance Specialist positions.
Highest Education Level
Quality Assurance Specialists in Chicago, IL 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
- Implementation
- Groundwater
- 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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