Quality Assurance Specialist Jobs in Fremont, 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.
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA (9 miles from Fremont, CA)
- 2 days ago
- Pleasanton, CA (9 miles from Fremont, CA)
- 2 days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Sr Regulatory Affairs Specialist (Remote) - Shockwave
- Santa Clara, CA (14 miles from Fremont, CA)
- 2 days ago
- Santa Clara, CA (14 miles from Fremont, 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- South San Francisco, CA (24 miles from Fremont, CA)
- 8 days ago
- South San Francisco, CA (24 miles from Fremont, CA)
- 8 days ago
Position Overview: The Quality Assurance Associate will provide support for internal and external activities to support GxP operations. This role's primary functions include management of...
- Sunnyvale, CA (12 miles from Fremont, CA)
- 11 days ago
- Sunnyvale, CA (12 miles from Fremont, 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 (11 miles from Fremont, CA)
- 12 days ago
- Mountain View, CA (11 miles from Fremont, 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...
Principal Regulatory Affairs Specialist - Heart Failure (on-site)
- Pleasanton, CA (9 miles from Fremont, CA)
- 15 days ago
- Pleasanton, CA (9 miles from Fremont, CA)
- 15 days ago
Chemistry, life Sciences, Biology (or equivalent vocational qualifications) Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices....
Senior Regulatory Affairs Specialist, NPD
- Sunnyvale, CA (12 miles from Fremont, CA)
- 15 days ago
- Sunnyvale, CA (12 miles from Fremont, 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 (16 miles from Fremont, CA)
- 18 days ago
- San Jose, CA (16 miles from Fremont, 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 (13 miles from Fremont, CA)
- 18 days ago
- Menlo Park, CA (13 miles from Fremont, 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 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...
- Cupertino, CA (19 miles from Fremont, CA)
- 25 days ago
- Cupertino, CA (19 miles from Fremont, CA)
- 25 days ago
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 (14 miles from Fremont, CA)
- 30+ days ago
- Stanford, CA (14 miles from Fremont, 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....
Senior Compliance Manager- Program Operations (Healthcare Compliance Office)
- South San Francisco, CA (24 miles from Fremont, CA)
- 30+ days ago
- South San Francisco, CA (24 miles from Fremont, CA)
- 30+ days ago
The Position KEY ACCOUNTABILITIES Serves as the business owner for Funding Operations and/or Advisory Board Operations systems; navigation within the system may be up to 80% of the role. Review,...
- Cupertino, CA (19 miles from Fremont, CA)
- 30+ days ago
- Cupertino, CA (19 miles from Fremont, CA)
- 30+ days ago
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 (15 miles from Fremont, CA)
- 45+ days ago
- Redwood City, CA (15 miles from Fremont, 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...
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Salary for Quality Assurance Specialist Jobs in Fremont, CA
Required or preferred licenses and certifications for Quality Assurance Specialist positions.
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Quality Assurance Specialists in Fremont, 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
- GFSI
- Supplier Auditing
- Comprehensive Capital Analysis and Review
- 21 CFR 820
- Institutional Review Board
- ICH Guidelines
- Environmental Monitoring
- Biology
- 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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