Quality Assurance Specialist Jobs in Berkeley, 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.
- South San Francisco, CA (16 miles from Berkeley, CA)
- 8 days ago
- South San Francisco, CA (16 miles from Berkeley, 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...
Clinical Senior Compliance Analyst
- San Francisco, CA (10 miles from Berkeley, CA)
- 9 days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 9 days ago
Clinical Senior Compliance Analyst University of California, United States about 7 hours ago Location: San Francisco, CALIFORNIA Deadline: ; Clinical Enterprise Comp Full Time 80595BR Job Summary...
Remote WorkFinance Risk Compliance - Consultant/Manager
- San Francisco, CA (10 miles from Berkeley, CA)
- 12 days ago
- San Francisco, CA (10 miles from Berkeley, 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...
Quality Site & Contract Compliance Manager - Facility Operations
- San Francisco, CA (10 miles from Berkeley, CA)
- 12 days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 12 days ago
Quality Site & Contract Compliance Manager - Facility Operations Job ID 206624 Posted 14-Feb-2025 Service line GWS Segment Role type Full-time Areas of Interest Workplace Strategy Location(s)...
, biology, chemistry, analytical chemistry, life sciences, or other related degree concentration Authorization to work in the United States indefinitely without restriction or sponsorship Position is...
Compliance Specialist (Saturday-Wednesday)
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 30+ days ago
At Klaviyo, we value the unique backgrounds, experiences and perspectives each Klaviyo (we call ourselves Klaviyos) brings to our workplace each and every day. We believe everyone deserves a fair...
Senior Compliance Manager- Program Operations (Healthcare Compliance Office)
- South San Francisco, CA (16 miles from Berkeley, CA)
- 30+ days ago
- South San Francisco, CA (16 miles from Berkeley, 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,...
- Alameda, CA (6 miles from Berkeley, CA)
- 60+ days ago
- Alameda, CA (6 miles from Berkeley, CA)
- 60+ 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
- San Francisco, CA (10 miles from Berkeley, CA)
- 60+ days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 60+ days ago
be exposed to dust The noise level in the work environment is usually quiet to moderate Will work in a fast-paced, team environment Minimum Qualifications: B.S. or B.A. in Science or Engineering (Biology...
- San Francisco, CA (10 miles from Berkeley, CA)
- 60+ days ago
- San Francisco, CA (10 miles from Berkeley, CA)
- 60+ days ago
Review Board practices and guidelines Knowledge and understanding of good clinical practices for clinical research Excellent written communication skills required in order to write IRB-required documents...
- Alameda, CA (6 miles from Berkeley, CA)
- 90+ days ago
- Alameda, CA (6 miles from Berkeley, CA)
- 90+ days ago
As a member of Penumbras internal audit team, you will play a key role in ensuring that Penumbra's lifesaving products meet the highest standards of safety and effectiveness, and in instilling a...
Senior Regulatory Affairs Specialist
- South San Francisco, CA (16 miles from Berkeley, CA)
- 90+ days ago
- South San Francisco, CA (16 miles from Berkeley, CA)
- 90+ days ago
Education Bachelors degree in biology, chemistry, bioengineering or related scientific area Skills and Qualifications Minimum of 8 years of IVD Regulatory Affairs experience required....
Remote WorkPrincipal Regulatory Affairs Specialist - US New Product Introduction - Diabetes Care (on-site)
- Alameda, CA (6 miles from Berkeley, CA)
- 90+ days ago
- Alameda, CA (6 miles from Berkeley, CA)
- 90+ days ago
Familiar with relevant regulatory requirements for medical devices, drugs and/or biologics including Quality Systems standards, clinical investigations, ICH guidelines....
Demographic Data for Berkeley, CA
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Salary for Quality Assurance Specialist Jobs in Berkeley, CA
Required or preferred licenses and certifications for Quality Assurance Specialist positions.
Highest Education Level
Quality Assurance Specialists in Berkeley, 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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