Quality Assurance Specialist Jobs in North Carolina
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.
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Integrated DNA Technologies (IDT), one of...
Compliance Specialist- remote on the East Coast!
- Wilmington, NC
- 5 days ago
- Wilmington, NC
- 5 days ago
Knowledge, Skills and Abilities: Excellent oral and written communication skills Strong organizational and time-management skills Extensive knowledge of the clinical trial process Comprehensive knowledge...
Remote WorkAzurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing...
Quality Assurance Associate II Title: QA Associate II Location: Durham, NC Industry: Pharmaceutical Salary: $33/hr. and up based on experience Employment Type: Contract We are a technology-forward...
trial activities, sponsor experience, must have worked within a GCP environment Solid knowledge of drug development and clinical trial processes, including related standards and documents....
Remote WorkReview Board....
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 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...
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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Required or preferred licenses and certifications for Quality Assurance Specialist positions.
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Quality Assurance Specialists in North Carolina 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
- Implementation
- Groundwater
- Document Control
- 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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