Quality Assurance Specialist Jobs in Irvine, CA
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.
- Pomona, CA (17 miles from Irvine, CA)
- 2 days ago
- Pomona, CA (17 miles from Irvine, CA)
- 2 days ago
Adecco US, Inc. QC Compliance Specialists in Pamona , California Adecco Healthcare and Life Sciences is currently recruiting for QC Compliance Specialists in Pomona, CA. This is an on-site...
Regulatory Affairs Analyst University of California Irvine Health
- Orange, CA (6 miles from Irvine, CA)
- 10 days ago
- Orange, CA (6 miles from Irvine, CA)
- 10 days ago
trials according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures....
Quality & Contract Compliance Manager - Facility Operations
- Irvine, CA
- 12 days ago
- Irvine, CA
- 12 days ago
Quality & Contract Compliance Manager - Facility Operations Quality & Contract Compliance Manager - Facility Operations Job ID 206624 Posted 14-Feb-2025 Service line GWS Segment Role type...
- Orange, CA (6 miles from Irvine, CA)
- 14 days ago
- Orange, CA (6 miles from Irvine, CA)
- 14 days ago
trials according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures....
Quality Assurance & Compliance Coordinator - Food Industry
- Irvine, CA
- 18 days ago
- Irvine, CA
- 18 days ago
Qualifications Associates (AA) or Bachelor's (BA/BS) degree in Food Science, Nutrition, Microbiology, Biology, or a related field. 3 years of experience in the food industry QA, regulatory compliance...
Bachelor's degree in food science, nutrition, biology or related field. At least 3 years of experience in the food industry QA, regulatory compliance, or product development....
AIM OF THE POSITION The Senior Compliance Specialist will serve as a subject matter expert and assist with the development and implementation of a best practices surrounding ethical interactions...
/ Pharmacy/ Engineering/ Other Related Subject 2-4 years CMC Regulatory experience Bachelors Degree: Chemistry/ Biology/ Pharmacy/ Engineering/ Other Related Subject 2-4 years CMC Regulatory experience...
Human Resources Compliance Specialist
- Santa Ana, CA (6 miles from Irvine, CA)
- 45+ days ago
- Santa Ana, CA (6 miles from Irvine, CA)
- 45+ days ago
Foundation Building Materials (FBM) is a leading North American distributor of building materials focused on meeting and exceeding the needs of local construction trades with best-in-class...
- City of Industry, CA (23 miles from Irvine, CA)
- 45+ days ago
- City of Industry, CA (23 miles from Irvine, CA)
- 45+ days ago
Qualifications MINIMUM QUALIFICATIONS: Education and experience equivalent to: Education/Certification: Bachelors degree in food science, food microbiology, biology or equivalent from an accredited...
Demographic Data for Irvine, CA
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Required or preferred licenses and certifications for Quality Assurance Specialist positions.
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Quality Assurance Specialists in Irvine, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Consulting
- Decision Making
- Environmental Compliance
- Environmental Management
- Quality Systems
- ISO Certified
- Treasury
- Implementation
- Securities and Exchange Commission
- Balance Sheets
- Treasury Management
- Inspections
- ISO 13485
- Quality Management Systems
- Environmental Education
- Capital Markets
- Anti-Money Laundering
- Management Consulting
- ISO 14001
- Certified Hazardous Materials Manager
- HACCP Certified
- GxP
- GFSI
- Supplier Auditing
- Comprehensive Capital Analysis and Review
- 21 CFR 820
- Institutional Review Board
- ICH Guidelines
- Environmental Monitoring
- Biology
- Biotechnology
- Environmental Science
- Genetics
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Standard Operating Procedures
- Engineering
- Affirmative Action
- Strategy Development
- Risk Management
- Investigation
- Auditing
- Written Communication
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Microsoft PowerPoint
- Regulations
- Policy Development
- Project Management
- Research Skills
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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