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.
Please Note: This position is a night shift position that operates on a 2-2-3 schedule and is eligible for a shift differential. JOB SUMMARY: The incumbent will support GMP downstream...
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...
., Biology, Microbiology, Chemistry, Engineering, etc. or equivalent combination of education and experience; 3-5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing...
United Therapeutics Senior GPS Quality, Training & Compliance Manager in Research Triangle Park , North Carolina California, US residents click here (. The job details are as follows: Who we are...
Labcorp is searching for a Corporate Compliance Officer to support its health systems, national accounts, and payor solutions business teams as a member of the Corporate Compliance Department,...
Senior Corporate Compliance Manager - Training, Communications & Policy
- Rtp, NC (6 miles from Durham, NC)
- 60+ days ago
- Rtp, NC (6 miles from Durham, NC)
- 60+ 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....
- Morrisville, NC (10 miles from Durham, NC)
- 60+ days ago
- Morrisville, NC (10 miles from Durham, NC)
- 60+ days ago
Background: The ideal candidate will have a bachelors degree in a science-related or engineering discipline such as Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Chemistry, or Biology...
Senior Quality Assurance Associate
- Raleigh, NC (21 miles from Durham, NC)
- 60+ days ago
- Raleigh, NC (21 miles from Durham, NC)
- 60+ days ago
OVERVIEW We are currently searching for a skilled professional to join a well-known client’s team as a Senior Quality Assurance Associate in Raleigh, North Carolina. The Senior Quality Assurance...
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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
- Verbal Communication
- Filing
- Environmental Compliance
- NEPA
- CERCLA
- Environmental Management
- Quality Systems
- ISO Certified
- Implementation
- Air Quality
- Inspections
- ISO 13485
- Clean Water Act
- Environmental Education
- Clean Air Act
- Natural Resource Management
- ISO 14001
- Certified Hazardous Materials Manager
- Reimbursement
- GxP
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Clinical Data Management
- Good Clinical Practice
- Gene Therapy
- ICH Guidelines
- Field Sampling
- Biology
- Ecology
- Pharmacovigilance
- Good Laboratory Practice
- Biotechnology
- Clinical Trials
- Clinical Research
- Environmental Science
- Genetics
- FDA Regulations
- Medical Device Sales
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Microsoft PowerPoint
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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