Quality Assurance Specialist Jobs in Raleigh, NC
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.
Senior Regulatory Affairs Specialist - Plant Health
- Novozymes
- Durham, NC (21 miles from Raleigh, NC)
- 3 days ago
- Durham, NC (21 miles from Raleigh, NC)
- 3 days ago
Required qualifications: Bachelor's degree in a relevant field (e.g., Biology, Microbiology, Chemistry, Biotechnology, Agronomy, Plant Pathology, Toxicology, or similar) Minimum 5+ years of relevant...
In PersonSterility Assurance Lead Apply Now Applied To save a job sign in or get started Job ID: 9337271 Posted today Back Raleigh, NC, US Scientific Bachelors Degree Full Time, Temporary...
In PersonGlobal CDMO Compliance Officer
- FUJIFILM Diosynth Biotechnologies
- Morrisville, NC (11 miles from Raleigh, NC)
- 27 days ago
- Morrisville, NC (11 miles from Raleigh, NC)
- 27 days ago
Position Overview FUJIFILM Holdings America Corporation is seeking an accomplished, talented, and highly motivated individual to serve as Global CDMO Compliance Officer for its FUJIFILM...
HybridEducation and Experience: Bachelor's Degree preferably in Microbiology, Biology or similar life science 7+ years of experience in sterile manufacturing (preferably in pharmaceutical manufacturing),...
In PersonDemographic Data for Raleigh, NC
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Salary for Quality Assurance Specialist Jobs in Raleigh, NC
Highest Education Level
Quality Assurance Specialists in Raleigh, NC offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Environmental Compliance
- Environmental Planning
- Quality Systems
- 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
- 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
- Military Background
- Auditing
- Written Communication
- Investigation
- Quality Assurance
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Collaboration
- Education Experience
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Excel
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Leadership
- Communication Skills
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