QA Specialist II

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

Key Responsibilities:

• Perform a wide variety of activities to ensure compliance with applicable regulatory requirements.
• Participate in the development of Standard Operating Procedures (SOPs) to meet quality objectives.
• Maintain routine programs and processes to ensure high-quality products and compliance with GMP and GLP standards.
• Review manufacturing, environmental monitoring, and quality control data for in-process and finished products.
• Work directly with operational teams to ensure inspections, statistical process control analyses, and audits are conducted regularly to enforce requirements and meet specifications.
• Participate in writing annual product reviews and developing training programs related to quality product production.
• Lead or coordinate investigations and corrective and preventive action (CAPA) recommendations for manufactured products.
• Collaborate with Research and Development during new product start-ups and identify checkpoints for new products and processes.
• Work independently on routine tasks and receive general instructions for new assignments.

Basic Qualifications:

• BS degree with 4+ years of relevant experience in a GMP-related field, or
• MS degree with 2+ years of relevant experience.
• Working knowledge of GMPs and/or GLPs.
• Familiarity with quality assurance systems, methods, and procedures.
• Knowledge of FDA/EMEA standards and quality systems.
• Basic understanding of Six Sigma, LEAN, and root cause analysis tools.
• Strong audit, investigation, and report writing skills.
• Good verbal, written, and interpersonal communication skills.
• Proficiency in Microsoft Office applications.

Preferred Qualifications:

• Prior experience in the pharmaceutical industry.
• Experience supporting regulatory inspections and quality audits.
• Ability to work independently and collaboratively in a cross-functional environment.
• Strong organizational and planning skills.

 

The salary range for this position is: $102,085.00 - $132,110.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national o