Quality Assurance Specialist Jobs in Wisconsin
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.
Come Be Part of a Mission that Matters! The Quality Compliance Manager is responsible for ensuring that departmental activities align with quality goals and objectives. This role involves...
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Quality Assurance Specialists in Wisconsin offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- English
- Accounting
- Driving
- Filing
- Quality Systems
- ISO Certified
- Implementation
- Change Control
- ISO 13485
- Quality Management Systems
- Internal Audits
- GxP
- TrackWise
- 21 CFR 820
- ICH GCP
- Institutional Review Board
- Good Clinical Practice
- ICH Guidelines
- Medical Affairs
- Cell Culture
- Scientific Research
- Biology
- Biochemistry
- Drug Development
- Microbiology
- Environmental Monitoring
- Biomedical Engineering
- Stem Cells
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Animal Care
- Medical Device Sales
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Auditing
- Investigation
- Written Communication
- Education Experience
- Interpersonal Skills
- Quality Assurance
- Collaboration
- Documentation
- Reporting
- Policy Development
- Bachelor's Degree
- Regulations
- Microsoft Office
- Problem Solving
- Research Skills
- Microsoft Excel
- Organization
- Scheduling
- Leadership
- Communication Skills
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