Quality Assurance Specialist Jobs in Sunnyvale, 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.
Staff Regulatory Affairs Specialist - Hybrid
- Milpitas, CA (11 miles from Sunnyvale, CA)
- 6 hours ago
- Milpitas, CA (11 miles from Sunnyvale, CA)
- 6 hours ago
., biomedical engineering, engineering, computer science, biology, medical technology, chemistry or related science, etc.) preferred....
Regulatory Affairs Specialist - Hybrid
- Milpitas, CA (11 miles from Sunnyvale, CA)
- 10 days ago
- Milpitas, CA (11 miles from Sunnyvale, CA)
- 10 days ago
support to international registrations and product release to market activities About You: B.S. degree in health science or life science field (biomedical engineering, engineering, computer science, biology...
Compliance Specialist IV Job Description Job Title - Compliance Specialist (Environmental Engineer) Duration - 9+ Months Location - Sunnyvale, CA Summary The Environmental Engineer is responsible...
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 (7 miles from Sunnyvale, CA)
- 45+ days ago
- San Jose, CA (7 miles from Sunnyvale, CA)
- 45+ 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...
Clinical Research Project and Quality & Compliance Manager, Emergency Medicine (Hybrid Opportunity)
- Stanford, CA (8 miles from Sunnyvale, CA)
- 60+ days ago
- Stanford, CA (8 miles from Sunnyvale, CA)
- 60+ 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....
Senior Director, Compliance Officer
- Redwood City, CA (13 miles from Sunnyvale, CA)
- 60+ days ago
- Redwood City, CA (13 miles from Sunnyvale, CA)
- 60+ 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...
Vice President, Compliance & Privacy, Chief Compliance Officer #4025
- Menlo Park, CA (10 miles from Sunnyvale, CA)
- 90+ days ago
- Menlo Park, CA (10 miles from Sunnyvale, 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...
Demographic Data for Sunnyvale, CA
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Salary for Quality Assurance Specialist Jobs in Sunnyvale, CA
Highest Education Level
Quality Assurance Specialists in Sunnyvale, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Quality Assurance Specialist position
- Verbal Communication
- Filing
- Environmental Compliance
- NEPA
- CERCLA
- Environmental Management
- Quality Systems
- ISO Certified
- Implementation
- Air Quality
- Inspections
- ISO 13485
- Clean Water Act
- Environmental Education
- Clean Air Act
- Natural Resource Management
- ISO 14001
- Certified Hazardous Materials Manager
- Reimbursement
- Internal Audits
- GxP
- 21 CFR 820
- Institutional Review Board
- ICH GCP
- Clinical Data Management
- Good Clinical Practice
- Gene Therapy
- ICH Guidelines
- Field Sampling
- Biology
- Ecology
- Pharmacovigilance
- Good Laboratory Practice
- Biotechnology
- Clinical Trials
- Clinical Research
- Environmental Science
- Genetics
- FDA Regulations
- Medical Device Sales
- Corrective Actions & Preventive Actions
- Good Manufacturing Practices
- Standard Operating Procedures
- Engineering
- Affirmative Action
- Strategy Development
- Quality Control
- Investigation
- Written Communication
- Auditing
- Documentation
- Quality Assurance
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Microsoft PowerPoint
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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