Quality Assurance Specialist Jobs in Rtp, 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.
Manufacturing Compliance Specialist I/II
- Durham, NC (6 miles from Rtp, NC)
- 6 days ago
- Durham, NC (6 miles from Rtp, NC)
- 6 days ago
Position Summary: The incumbent will support GMP manufacturing operations for late-phase and commercial mammalian Cell Culture programs and oversee compliance activities for the department....
Principal Regulatory Affairs Specialist, Pharmaceutical Products (Hybrid)
- Raleigh, NC (16 miles from Rtp, NC)
- 6 days ago
- Raleigh, NC (16 miles from Rtp, NC)
- 6 days ago
Compliance & Risk Management Ensure adherence to current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and other applicable quality standards....
Manufacturing Compliance Specialist I/II (Nights)
- Durham, NC (6 miles from Rtp, NC)
- 15 days ago
- Durham, NC (6 miles from Rtp, NC)
- 15 days ago
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....
- Durham, NC (6 miles from Rtp, NC)
- 21 days ago
- Durham, NC (6 miles from Rtp, NC)
- 21 days ago
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...
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Senior GPS Quality, Training & Compliance Manager
- Durham, NC (6 miles from Rtp, NC)
- 45+ days ago
- Durham, NC (6 miles from Rtp, NC)
- 45+ days ago
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...
Senior Corporate Compliance Manager - Training, Communications & Policy
- Rtp, NC
- 60+ days ago
- Rtp, 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 (4 miles from Rtp, NC)
- 60+ days ago
- Morrisville, NC (4 miles from Rtp, 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...
Demographic Data for Rtp, NC
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Salary for Quality Assurance Specialist Jobs in Rtp, NC
Highest Education Level
Quality Assurance Specialists in Rtp, 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
- Environmental Compliance
- Waste Management
- Environmental Management
- Affirmative Action
- Quality Systems
- ISO Certified
- Implementation
- Air Quality
- Inspections
- ISO 13485
- Environmental Education
- ISO 14001
- Certified Hazardous Materials Manager
- GxP
- TrackWise
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Clinical Data Management
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Field Sampling
- Drug Development
- Biology
- Pharmacovigilance
- Stem Cells
- Good Laboratory Practice
- Clinical Trials
- Biotechnology
- Environmental Science
- Clinical Research
- Genetics
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Engineering
- Strategy Development
- Risk Management
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Microsoft PowerPoint
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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