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.
Senior Regulatory Affairs Specialist (on-site)
- Santa Clara, CA
- 2 hours ago
- Santa Clara, CA
- 2 hours ago
Provides mentoring and leadership to other Regulatory team members Required Qualifications Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology...
Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors....
This person will bring a strong knowledge of research regulations and guidelines, including those related to human subjects’ research, research privacy, data management, Institutional Review Board (...
Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and...
QA Technician Fairfield, CA We are in search of a QA Technician for our client in Vacaville. As a QA Technician you will perform laboratory tests to ensure water control systems and food products...
#LI-DB1 skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions, ICH Regulations Equal Opportunity Employer: Race...
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, one of Danahers 15+ operating companies,...
- Berkeley, CA
- 2 days ago
- Berkeley, CA
- 2 days ago
Research Compliance Analyst 3 (6230U), Research Admin & Compliance - 79267 About Berkeley At the University of California, Berkeley, we are dedicated to fostering a community where everyone feels...
Remote WorkResearch Compliance Analyst 3 (6230U), Research Admin & Compliance - 79267
- San Francisco, CA
- 2 days ago
- San Francisco, CA
- 2 days ago
Research Compliance Analyst 3 (6230U), Research Admin & Compliance - 79267 About Berkeley At the University of California, Berkeley, we are dedicated to fostering a community where everyone feels...
Remote Work$41.13 to $49.99 Hourly with a 5% COLA on 7/1/26 Our newly operational Water Resources Center sets the standard for wastewater treatment facilities on the Central Coast. Its the Citys largest-ever...
trials and to the market....
Senior Associate Quality Assurance / Associate Qua
- Thousand Oaks, CA
- 22 days ago
- Thousand Oaks, CA
- 22 days ago
Education Qualification - Preferred: Bachelor's Degree in Biochemistry, Biology, Chemistry, or related scientific disciplines....
Quality Assurance Associate, Sterile Injectables
- Sacramento, CA
- 28 days ago
- Sacramento, CA
- 28 days ago
Kelly Science & Clinical is seeking a Quality Assurance Associate for a direct hire opportunity with a leading specialty pharmaceutical company at their R&D center in Davis, CA. If you are driven...
trials Prior experience with regulatory submission writing Demonstrated understanding of product development process and design controls Demonstrated knowledge of FDA, EU and/or international regulations...
Staff International Regulatory Affairs Specialist
- San Diego, CA
- 30+ days ago
- San Diego, CA
- 30+ days ago
Summary As Staff Regulatory Affairs Specialist, you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and Non-Medical Devices along with associated Software...
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Required or preferred licenses and certifications for Quality Assurance Specialist positions.
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
- English
- Accounting
- Driving
- Filing
- Financial Services
- Quality Systems
- ISO Certified
- Implementation
- Change Control
- ISO 13485
- Quality Management Systems
- Internal Audits
- GxP
- TrackWise
- 21 CFR 820
- ICH GCP
- Institutional Review Board
- Good Clinical Practice
- ICH Guidelines
- Medical Affairs
- Scientific Research
- Ecology
- Biology
- Biochemistry
- Drug Development
- Microbiology
- Environmental Monitoring
- Biomedical Engineering
- Biotechnology
- Good Laboratory Practice
- Clinical Trials
- Clinical Research
- Animal Care
- Medical Device Sales
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Auditing
- Investigation
- Written Communication
- Education Experience
- Documentation
- Quality Assurance
- Interpersonal Skills
- Collaboration
- Reporting
- Policy Development
- Bachelor's Degree
- Regulations
- Microsoft Office
- Problem Solving
- Research Skills
- Microsoft Excel
- Organization
- Scheduling
- Leadership
- Communication Skills
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