Quality Assurance Specialist Jobs in Durham, 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.
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new...
Requirements: Education: / Skills: BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Engineering, etc. or equivalent combination of education and experience; 3-5 years of pharmaceutical...
JOB SUMMARY: The incumbent will support GMP downstream manufacturing operations for late-phase and commercial mammalian Cell Culture programs and oversee compliance activities for the department....
Job Description Summary This position will be located at Durham, NC and will not have the ability to be located remotely. The Sterility Assurance Lead serves as the key functional expert for...
Senior GPS Quality, Training & Compliance Manager
- Rtp, NC (6 miles from Durham, NC)
- 90+ days ago
- Rtp, NC (6 miles from Durham, NC)
- 90+ days ago
California, US residents click here. The job details are as follows: Who we are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation....
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Salary for Quality Assurance Specialist Jobs in Durham, NC
Highest Education Level
Quality Assurance Specialists in Durham, NC 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
- Financial Services
- Quality Systems
- ISO Certified
- Geology
- Water Quality
- Implementation
- Air Quality
- Document Control
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Environmental Education
- Natural Resource Management
- Batch Record Review
- GxP
- TrackWise
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- ICH Guidelines
- Lab Safety
- Biology
- Drug Development
- Pharmacovigilance
- Microbiology
- Environmental Monitoring
- Biotechnology
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Military Background
- Auditing
- Investigation
- Written Communication
- Interpersonal Skills
- Quality Assurance
- Collaboration
- Education Experience
- Documentation
- Reporting
- Bachelor's Degree
- Regulations
- Policy Development
- Microsoft Office
- Problem Solving
- Research Skills
- Microsoft Excel
- Organization
- Scheduling
- Leadership
- Communication Skills
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