QA Specialist I

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 lifechanging 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

Gileads mission is to discover develop and deliver therapies that will improve the lives of patients with lifethreatening illnesses

worldwide. As a QA Specialist I you are responsible for:

Key Responsibilities:

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

Compile and verify all batch related documents are complete to support lot release.

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

Elevate any issues affecting lot manufacturing or release to Management in a timely manner

Ensure that any Deviations in executed Manufacturing Production Records are appropriately identified

Ensure that manufacturing Deviation Change Management and other records to support lot release are acceptable.

Prioritize lot release of various product types (sterile/parenteral solid dose finished goods and clinical)

Gather metrics related to lot release quarterly business reviews and annual product reviews

May develop training programs related to Batch Record Review and Release processes

Participate in revision of Batch Record Review and Release SOPs/forms

Basic Qualifications:

Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs).

Demonstrates basic knowledge of FDA / EMEA standards and quality systems.

Demonstrates good verbal written and interpersonal communication skills.

Demonstrates working knowledge in Microsoft Office applications.

Specific Education & Experience Requirements:

BS with at least 2 years of relevant experience in a GMP environment.

OR

AA degree with at least 3 years of relevant experience in a GMP environment.

Preferred Qualifications:

At least 4 years of relevant experience in Quality Assurance Quality Control or a cGMP related field within a biotechnology biologics or pharmaceutical manufacturing facility

Working knowledge of cGMP quality systems and regulatory requirements (21 CRF Part 11/210/211 etc.) practices/principles

General knowledge of aseptic manufacturing processes

Experience with information systems (LIMS MES Oracle EBS)

Experience with internal and external audit

Experience with Health Authority Regulations and Validation practices/principles

Knowledge of IQ/OQ/PQ

For additional benefits information visit:

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 origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob related characteristics or other prohibited grounds specified in applicable federal state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.