QA Specialist II

Gilead Sciences•La Verne, CA

3d•$92,820 - $120,120•Onsite

About The Position

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. This is an onsite role.

Requirements

Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
Demonstrates working knowledge of quality assurance systems, methods and procedures.
Demonstrates knowledge of FDA / EMEA standards and quality systems.
Demonstrates basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
Demonstrates audit and investigation skills, and report writing skills.
Demonstrates good verbal, written, and interpersonal communication skills.
Demonstrates proficiency in Microsoft Office applications.
4+ years of relevant experience in a GMP environment related field and a BS. OR 2 + years of relevant experience in a GMP environment related field and a MS.

Nice To Haves

Prior experience in pharmaceutical industry is preferred.

Responsibilities

Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
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).
Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
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 participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
Works with Research and Development during new product start-ups and identifies checkpoints for new products and processes.