Quality Assurance Specialist II

For Current Gilead Employees and Contractors:

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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
 

Responsibilities:

• Review and approve master batch records, labels, specifications and other pre-production documents for Clinical/Commercial intermediates, drug substance, drug product, and packaging and labeling in compliance with FDA and international health agency requirements. 

• Review executed production batch records, environmental monitoring data (as required), analytical data, and associated documentation, including any deviation and investigation reports related to lot release of Clinical/Commercial intermediates, drug substance, drug product, and packaging and labeling in support of product disposition.

• Lead or coordinate investigations and corrective and preventive action (CAPA) recommendations

• Interface directly with contract manufacturers and alliance partners to manage quality related issues with minimal supervision.

• Interact with key stakeholders such as Formulation and Process Development, Manufacturing, Engineering, Packaging, and Regulatory Affairs to ensure that Clinical/Commercial material is manufactured in accordance with established procedures, cGMPs, and appropriate regulations.

• Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues.

• Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.

• Write, revise, and review standard operating procedures.

• Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met. 

• Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices GLPs). 

• Works with Research and Development during new product start-ups and identifies checkpoints for new products and processes. 

• Normally receives very little instruction on routine work, general instructions on new assignments.

• Assist in departmental planning activities to ensure that deliverables are provided according to project timelines

Required Skills:

• Good working knowledge of Quality Systems, FDA/EMEA Standards, current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)

• Excellent knowledge of six sigma, LEAN and root cause analysis tools for identifying and correcting deviations

• Ability to work on complex, non-routine assignments where analysis of the situation or data requires