Quality Assurance Specialist Jobs in Pleasanton, 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.
- Palo Alto, CA (21 miles from Pleasanton, CA)
- 4 days ago
- Palo Alto, CA (21 miles from Pleasanton, CA)
- 4 days ago
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....
Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)
- Milpitas, CA (15 miles from Pleasanton, CA)
- 30+ days ago
- Milpitas, CA (15 miles from Pleasanton, CA)
- 30+ days ago
Influences middle management on technical or business solutions Required Qualifications Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology,...
Regulatory Affairs Specialist - Pleasanton, CA
- Pleasanton, CA
- 30+ days ago
- Pleasanton, CA
- 30+ days ago
Clinical Practices (GCPs)....
Vice President, Compliance Officer
- Redwood City, CA (24 miles from Pleasanton, CA)
- 30+ days ago
- Redwood City, CA (24 miles from Pleasanton, CA)
- 30+ days ago
About Soleno Therapeutics Inc Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare...
Clinical Research Project and Quality & Compliance Manager, Emergency Medicine (Hybrid Opportunity)
- Stanford, CA (23 miles from Pleasanton, CA)
- 90+ days ago
- Stanford, CA (23 miles from Pleasanton, CA)
- 90+ days ago
Expert knowledge of regulatory affairs, including IRB review and approval process and Good Clinical Practice. Knowledge of International Conference on Harmonization (ICH) standards....
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Salary for Quality Assurance Specialist Jobs in Pleasanton, CA
Highest Education Level
Quality Assurance Specialists in Pleasanton, CA 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
- Financial Services
- Quality Systems
- ISO Certified
- Geology
- Water Quality
- Implementation
- Air Quality
- Document Control
- Change Control
- Inspections
- ISO 13485
- Quality Management Systems
- Environmental Education
- Natural Resource Management
- Batch Record Review
- GxP
- TrackWise
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- ICH Guidelines
- Lab Safety
- Biology
- Drug Development
- Pharmacovigilance
- Microbiology
- Environmental Monitoring
- Biotechnology
- Clinical Trials
- Clinical Research
- Laboratory Management
- Medical Device Sales
- FDA Regulations
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- 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
- Research Skills
- Microsoft Excel
- Organization
- Scheduling
- Leadership
- Communication Skills
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