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.
Company Description Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is...
This is the century of biology, and the breakthroughs we make now have the potential to change the world....
Staff International Regulatory Affairs Specialist
- Los Angeles, CA
- 3 days ago
- Los Angeles, CA
- 3 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...
Research Compliance Manager California State University, Fullerton
- Fullerton, CA
- 5 days ago
- Fullerton, CA
- 5 days ago
Review Board (IRB)/human subjects protection administration....
Senior Associate Quality Assurance / Associate Qua
- Thousand Oaks, CA
- 8 days ago
- Thousand Oaks, CA
- 8 days ago
Education Qualification - Preferred: Bachelor's Degree in Biochemistry, Biology, Chemistry, or related scientific disciplines....
Quality Assurance Associate, Sterile Injectables
- Sacramento, CA
- 14 days ago
- Sacramento, CA
- 14 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...
Principal Regulatory Affairs Specialist (Business Partnerships).
- Alameda, CA
- 14 days ago
- Alameda, CA
- 14 days ago
Chemistry, life Sciences, Biology (or equivalent vocational qualifications) Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices....
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...
Regulatory Affairs Specialist II DiaSorin United States, California, Cypress 11331 Valley View Street (Show on map) Jun 14, 2025 Diasorin is a global leader in diagnostic solutions, pushing the...
Staff International Regulatory Affairs Specialist
- San Diego, CA
- 19 days ago
- San Diego, CA
- 19 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...
Minimum Qualifications: AA, AS in Chemistry, Biochemistry, Biological Sciences, or a similar scientific field, or an equivalent combination of education and experience....
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...
Senior SOX Compliance Analyst Vaco $85,000.00 - $115,000.00 / yr United States, California, La Jolla Jun 07, 2025 About Vaco: Vaco provides expert consulting, permanent placement, executive...
- South San Francisco, CA
- 21 days ago
- South San Francisco, CA
- 21 days ago
Principal Healthcare Compliance Manager, Healthcare Compliance Office (HCO), Compliance Operations & Training The Opportunity As the Principal Healthcare Compliance Manager, you'll contribute...
trial purposes to commercial production....
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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
- Driving
- Environmental Compliance
- Quality Systems
- ISO Certified
- Geology
- Implementation
- Air Quality
- Document Control
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Environmental Education
- Batch Record Review
- GxP
- TrackWise
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- ICH Guidelines
- Good Clinical Practice
- Lab Safety
- Biology
- Drug Development
- Environmental Monitoring
- Microbiology
- Biotechnology
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- Data Science
- FDA Regulations
- Corrective Actions & Preventive Actions
- Research and Development
- Good Manufacturing Practices
- Standard Operating Procedures
- Machine Learning
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Military Background
- Auditing
- Investigation
- Written Communication
- Interpersonal Skills
- Quality Assurance
- Collaboration
- Education Experience
- Documentation
- Reporting
- Bachelor's Degree
- Regulations
- Policy Development
- Microsoft Office
- Problem Solving
- Sales
- Research Skills
- Microsoft Excel
- Organization
- Scheduling
- Leadership
- Communication Skills
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