Quality Assurance Specialist Jobs in Cupertino, 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.
Sr Regulatory Affairs Specialist (Remote) - Shockwave
- Santa Clara, CA (8 miles from Cupertino, CA)
- 2 days ago
- Santa Clara, CA (8 miles from Cupertino, CA)
- 2 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 Work- Sunnyvale, CA (7 miles from Cupertino, CA)
- 11 days ago
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 11 days ago
Compliance Specialist IV Job Description Job Title - Compliance Specialist (Environmental Engineer) Duration - 9+ Months Location - Sunnyvale, CA Summary The Environmental Engineer is responsible...
Finance Risk Compliance - Consultant/Manager
- Mountain View, CA (8 miles from Cupertino, CA)
- 12 days ago
- Mountain View, CA (8 miles from Cupertino, CA)
- 12 days ago
Job Description In Strategy & Consulting we work with C-suite executives, leaders and boards of the world's leading organizations, helping them reinvent every part of their enterprise to drive...
Senior Regulatory Affairs Specialist, NPD
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 15 days ago
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 15 days ago
Kelly Science & Clinical is currently recruiting for a Senior Regulatory Affairs Specialist for a 2-year contract opportunity with a leading molecular diagnostics company at their Sunnyvale, CA...
Sr. Regulatory Affairs Specialist I
- San Jose, CA (11 miles from Cupertino, CA)
- 18 days ago
- San Jose, CA (11 miles from Cupertino, CA)
- 18 days ago
Sr. Regulatory Affairs Specialist I Department: Quality Employment Type: Full Time Location: US-California-San Jose Compensation: $118,100 - $138,600 / year Description The Sr. Regulatory Affairs...
Vice President, Compliance & Privacy, Chief Compliance Officer #4025
- Menlo Park, CA (12 miles from Cupertino, CA)
- 18 days ago
- Menlo Park, CA (12 miles from Cupertino, CA)
- 18 days ago
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective...
Manufacturing Compliance Specialist
- Fremont, CA (19 miles from Cupertino, CA)
- 20 days ago
- Fremont, CA (19 miles from Cupertino, CA)
- 20 days ago
Manufacturing Compliance Specialist Manufacturing Fremont, CA, US Pay Rate Low: 45.00 | Pay Rate High: 49.00 Our client is a global, research-driven pharmaceutical focusing on treatment options...
Compliance Specialist Job Description Title: Compliance Specialist Location: Cupertino, CA 95014 (hybrid role, working 3 days onsite) Duration: 12 Months Assist Global Export and Sanctions...
Clinical Research Project and Quality & Compliance Manager, Emergency Medicine (Hybrid Opportunity)
- Stanford, CA (9 miles from Cupertino, CA)
- 30+ days ago
- Stanford, CA (9 miles from Cupertino, CA)
- 30+ 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....
Compliance Analyst Job Description Title: Compliance Analyst Location: Cupertino, CA 95014 Duration: 06 Months Description: The candidate will possess the following essential skills: Exceptional...
Senior Director, Compliance Officer
- Redwood City, CA (14 miles from Cupertino, CA)
- 45+ days ago
- Redwood City, CA (14 miles from Cupertino, CA)
- 45+ 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...
Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)
- Milpitas, CA (17 miles from Cupertino, CA)
- 90+ days ago
- Milpitas, CA (17 miles from Cupertino, CA)
- 90+ 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,...
Vice President, Compliance & Privacy, Chief Compliance Officer #4025
- Menlo Park, CA (12 miles from Cupertino, CA)
- 90+ days ago
- Menlo Park, CA (12 miles from Cupertino, CA)
- 90+ days ago
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective...
Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 90+ days ago
- Sunnyvale, CA (7 miles from Cupertino, CA)
- 90+ days ago
Biomedical Engineering, life Sciences, Biology (or equivalent qualifications) - 5-7 years of experience in regulatory submissions for In Vitro Diagnostic Devices, Pharmaceutical and/or Biologics (small...
Demographic Data for Cupertino, CA
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Salary for Quality Assurance Specialist Jobs in Cupertino, CA
Required or preferred licenses and certifications for Quality Assurance Specialist positions.
Highest Education Level
Quality Assurance Specialists in Cupertino, 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
- Supplier Auditing
- Comprehensive Capital Analysis and Review
- 21 CFR 820
- Institutional Review Board
- ICH Guidelines
- Environmental Monitoring
- Biology
- Clinical Trials
- 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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