Quality Assurance Specialist Jobs in California
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.
Principal Regulatory Affairs Specialist Heart Failure (on-site)
- Pleasanton, CA
- 20 days ago
- Pleasanton, CA
- 20 days ago
Chemistry, life Sciences, Biology (or equivalent vocational qualifications) Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices....
Principal Regulatory Affairs Specialist US New Product Introduction Diabetes Care (on-site)
- Alameda, CA
- 90+ days ago
- Alameda, CA
- 90+ days ago
Familiar with relevant regulatory requirements for medical devices, drugs and/or biologics including Quality Systems standards, clinical investigations, ICH guidelines....
: Policy Administration: Administer University policies related to animal and human subjects research, export controls, research security training, and research administration compliance. Evaluate...
Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)
- Sunnyvale, CA
- 19 hours ago
- Sunnyvale, CA
- 19 hours ago
Biomedical Engineering, life Sciences, Biology (or equivalent qualifications) - 5 years of experience in regulatory submissions for In Vitro Diagnostic Devices, Pharmaceutical and/or Biologics (small...
Review Board ( IRB ) and Institutional Animal Care and Use Committee ( IACUC ) for review....
Shared Services: Human Research and Compliance (Full-Time, Day Shift) - Job Summary: The Research Compliance Analyst will provide support for multiple research compliance areas including Research...
Biotechnology is rewriting life as we know it, from the medicines we take, to the crops we grow, the materials we wear, and the household goods that we rely on every day. But moving at the new...
Qualifications: Bachelor’s degree with preference for engineering or science background including environmental science, chemistry, geology, or biology....
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA
- 8 days ago
- Pleasanton, CA
- 8 days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
obtain security clearance to work on site at Federal facilities Drug screen required for this position Education and Experience BA or BS Degree in Environmental Science or Environmental Engineering, Biology...
Sr Regulatory Affairs Specialist (Remote) - Shockwave
- Santa Clara, CA
- 8 days ago
- Santa Clara, CA
- 8 days ago
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments....
Remote WorkPosition Overview: The Quality Assurance Associate will provide support for internal and external activities to support GxP operations. This role's primary functions include management of...
What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions...
Clinical Senior Compliance Analyst University of California, United States about 7 hours ago Location: San Francisco, CALIFORNIA Deadline: ; Clinical Enterprise Comp Full Time 80595BR Job Summary...
Remote WorkRegulatory Affairs Analyst University of California Irvine Health
- Orange, CA
- 15 days ago
- Orange, CA
- 15 days ago
trials according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures....
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Salary for Quality Assurance Specialist Jobs in California
Highest Education Level
Quality Assurance Specialists in California offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Financial Reporting
- Accounting
- Finance
- CPA
- Environmental Compliance
- Environmental Management
- Quality Systems
- Financial Statements
- Reconciliations
- Generally Accepted Accounting Principles
- Account Reconciliation
- Journal Entries
- Treasury
- Consolidation
- Securities and Exchange Commission
- Balance Sheets
- Treasury Management
- Internal Control
- Inspections
- ISO 13485
- Public Accounting
- Anti-Money Laundering
- Management Consulting
- Certified Hazardous Materials Manager
- HACCP Certified
- GxP
- Technical Accounting
- Comprehensive Capital Analysis and Review
- 21 CFR 820
- Institutional Review Board
- Real-Time Polymerase Chain Reaction
- ICH Guidelines
- Biology
- Environmental Science
- Genetics
- FDA Regulations
- Medical Device Sales
- Good Manufacturing Practices
- Corrective Actions & Preventive Actions
- Data Collection
- Standard Operating Procedures
- Engineering
- Strategy Development
- Risk Management
- Collections
- Investigation
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Bachelor's Degree
- Reporting
- Education Experience
- Regulations
- Policy Development
- Research Skills
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Organization
- Scheduling
- Leadership
- Communication Skills
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