QA Specialist

QA Specialist
Canada - OntarioCanada - QuebecCanada - Ontario - Toronto WestCanada - Ontario - Ontario EastCanada - Ontario - Mississauga

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

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At Gilead, Creating Possible drives everything we do. It's evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving the lives of people around the world and advancing the care of patients suffering from life-threatening diseases.

At Gilead, we are driven to develop life saving products that make a difference for patients around the world. Every day, we to transform the promise of science and technology into breakthrough, innovative therapies that have the power to cure, prevent or treat disease. As a research-based bio pharmaceutical company, we are revolutionizing healthcare by bringing medicines to patients in the areas of unmet need including HIV, AIDS, liver diseases, hematology and oncology, and inflammation and respiratory diseases. When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives.

The Role:

• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  
• Participates in developing Standard Operating Procedures to ensure quality objectives are met.
  
• Maintains programs and processes to ensure high quality products and compliance with current good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  
• Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
  
• Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
  
• Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
  
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
  
• May assist with compliance audits as required.
  
• Interfaces with contract manufacturers to address documentation and compliance issues.
  
• Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
  
• Normally receives no instruction on routine work, general instructions on new assignments.
  

Knowledge:

• Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
  
• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
  
• Demonstrates thorough knowledge of Health Canada standards and quality systems, and interfaces with other functions like manufacturing, distribution and maintenance.
  
• Demonstrates strong knowledge of root cause analysis tools used for identifying and correcting deviations
  
• Demonstrates audit and investigation skills, and report writing skills.
  
• Demonstrates strong verbal, technical writing and interpersonal skills.
  
• Demonstrates proficiency in Microsoft Office applications.
  

Specific Education & Experience Requirements:

• 6+ years of relevant experience in a GMP environment related field and BSc.
  
• 4+ years of relevant experience and a MS.
  
• Prior experience in pharmaceutical industry is preferred.
  

Gilead Core Values:

• Integrity (doing what\'s right)
  
• Teamwork (working together)
  
• Excellence (being your best)
  
• Accountability (taking personal responsibility)
  
• Inclusion (encouraging diversity)
  

Gilead Leadership Commitment:

• I AM BOLD in aspiration and AGILE in execution.
  
• I CARE and make time for people.
  
• I LISTEN, speak openly and explain the "why."
  
• I TRUST others and myself to make sound decisions.
  
• I OWN the impact of my words and actions.
  

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Canada---Ontario/QA-Specialist_R0022303-1





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