QA Specialist I

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
 

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening 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

 

The salary range for this position is: $80,325.00 - $103,950.00. 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 c