Quality Assurance Specialist Jobs
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.
It is the responsibility of all employees to comply with all applicable regulations e.g., Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) in the performance...
Remote WorkA Bachelors degree, or equivalent, in environmental science, biology, microbiology, chemistry or a related science field and two years of relevant experience are required....
Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are...
Review Board (IRB) and related regulatory support to the Principal Investigator (PI) and research team ensuring: 1) adherence to the protocol; 2) regulatory compliance; 3) protection of participant...
Minimum Education Associate's Degree Biology or a related discipline. (Required) Bachelor's Degree Biology or a related discipline....
Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) in the performance of their role....
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies Basic Minimum Qualifications: Bachelor's degree in biology...
Research Conflict of Interest %26 Conduct Compliance Analyst University of Maryland, Baltimore
- Baltimore, MD
- 1 day ago
- Baltimore, MD
- 1 day ago
Communicate with the Institutional Review Board (IRB) to resolve administrative modifications and address queries....
Preferred Qualifications Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields....
Requirements: Bachelors of Science in a related field such as Chemistry, Biology, Microbiology, or Food Science....
Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has...
Regulatory Affairs Coordinator (RAC) (Entry Senior Level)
- Sterling, VA
- 2 days ago
- Sterling, VA
- 2 days ago
Knowledge, Skills, and Abilities\: Knowledge and understanding of federal regulations and Good Clinical Practice (GCP). Ability to communicate effectively, both in writing and orally....
Research Conflict of Interest & Conduct Compliance Analyst
- Baltimore, MD
- 2 days ago
- Baltimore, MD
- 2 days ago
Communicate with the Institutional Review Board (IRB) to resolve administrative modifications and address queries....
Legal Operations & Contract Compliance Specialist
- Salt Lake City, UT
- 3 days ago
- Salt Lake City, UT
- 3 days ago
Who we are:** Rubrik is one of the fastest growing companies in Silicon Valley, revolutionizing data protection and management in the emerging multi-cloud IT industry. Recently a Top 10 of the...
Remote WorkRemote Research Regulatory Affairs Coordinator - All TxO Locations
- Dallas, TX
- 3 days ago
- Dallas, TX
- 3 days ago
Processes local and central Institutional Review Board submissions. Monitors and reports SAEs to sponsor/IRB....
Quality Assurance Specialist Online Courses and Training Opportunities
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Highest Education Level
Quality Assurance Specialists 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
- Quality Systems
- ISO Certified
- Water Quality
- Implementation
- Air Quality
- Inspections
- ISO 13485
- Environmental Education
- Natural Resource Management
- ISO 14001
- Environmental Engineering
- Certified Hazardous Materials Manager
- GxP
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Clinical Data Management
- Gene Therapy
- ICH Guidelines
- Good Clinical Practice
- Field Sampling
- Environmental Monitoring
- Biology
- Biotechnology
- Clinical Trials
- Good Laboratory Practice
- Environmental Science
- Clinical Research
- Genetics
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Machine Learning
- Engineering
- Strategy Development
- Process Improvement
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Interpersonal Skills
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Sales
- Policy Development
- Project Management
- Problem Solving
- Research Skills
- Microsoft Office
- Microsoft Excel
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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