QA Specialist II

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

Knowledge:

• 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.

Specific Education & Experience Requirements:

• Relevant experience in a GMP environment related field and a BS or MS.

• Prior experience in pharmaceutical industry is preferred.

Specific Job 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.

• Manage and execute the annual GMP refresher and GMP induction program across GSIUC

• May conduct or serve as a lead/coordinator of deviations and CAPA recommendations.

• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. These may include the running and design of weekly metrics for Training On Time Deviations On time CAPA closure and change controls along with other QA metrics.

• This role may be responsible for the weekly delivery of GMP Induction training and may be required to design and deliver annual GMP Refresher training. Also deliver one to one GMP training when business needs arises.

• Supporting both training and QA systems.

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

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.