
Quality Specialist 1
Welcome to Gilead Sciences! We are a cutting-edge biopharmaceutical company dedicated to creating innovative treatments for life-threatening diseases. As a Quality Specialist 1, you will play a vital role in ensuring the safety, efficacy, and quality of our products. We are seeking a highly detail-oriented and analytical individual with a passion for quality assurance and a strong understanding of FDA regulations. If you are looking for a challenging and rewarding career in the biopharmaceutical industry, we encourage you to apply for this exciting opportunity at Gilead Sciences.
- Conduct thorough quality checks and audits on all products and processes to ensure compliance with FDA regulations and company standards.
- Collaborate with cross-functional teams to identify and resolve any quality issues or concerns.
- Develop and maintain quality control procedures and documentation to ensure consistency and accuracy.
- Monitor and analyze data to identify trends and opportunities for improvement in product quality.
- Implement and maintain quality assurance systems and processes to support company objectives.
- Act as a subject matter expert on FDA regulations and industry standards, providing guidance and training to colleagues as needed.
- Investigate and respond to customer complaints related to product quality, working closely with customer service and other departments to ensure timely and effective resolution.
- Participate in product development and validation processes to ensure quality standards are met.
- Conduct risk assessments and develop risk management plans to address potential quality issues.
- Keep up-to-date with industry trends and changes in regulations, making recommendations for process improvements as needed.
- Communicate effectively with internal and external stakeholders, providing updates and reports on quality metrics and initiatives.
- Continuously monitor and evaluate quality processes and procedures, making recommendations for improvement and implementing changes as needed.
- Ensure adherence to all safety protocols and procedures in the quality control and assurance process.
- Maintain accurate and organized records and documentation to support quality control and assurance activities.
- Demonstrate a strong commitment to Gilead's mission and values, promoting a culture of quality and continuous improvement within the company.
Bachelor's Degree In A Scientific Or Related Field, Such As Biology, Chemistry, Or Pharmaceuticals.
Minimum Of 2-3 Years Of Experience In A Quality Control Or Quality Assurance Role Within The Pharmaceutical Industry.
Knowledge Of Fda Regulations And Guidelines, Including Gmp, Glp, And Gcp.
Strong Attention To Detail And Ability To Analyze Complex Data Sets.
Excellent Communication And Organizational Skills, With The Ability To Work Effectively In A Team And Independently.
Quality Assurance
Process Improvement
Data Analysis
Quality Control
Root Cause Analysis
Risk assessment
Document management
SOP Development
Regulatory Knowledge
Audit Compliance
Gmp Standards
Communication
Conflict Resolution
Customer Service
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Quality Specialist 1 in Foster City, CA, USA is between $60,000 to $75,000 per year.
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Gilead Sciences, Inc., is an American biotechnology company that researches, develops and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

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