Quality Assurance Associate

2 months ago

Edmonton, Canada Gilead Sciences Full time

Job Description

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

This role requires working effectively in a multi-disciplinary team on tasks that are semi-routine in nature where action and initiative are required in resolving problems and developing recommendations. Good verbal, written, and interpersonal communication skills are required. Knowledge and proficiency in Microsoft Office applications is required. Must be detail orientated, organized and able to complete multiple tasks through planning and prioritization.

The successful candidate will be a highly motivated person who demonstrates the ability to learn new knowledge quickly and resolve problems effectively.

Essential Job Duties & Responsibilities:

Performs Quality Assurance tasks that supports GMP-compliant operations in an API manufacturing facility.

Drafts technical documents, such as specifications and operating instructions, based upon information provided by other departments, standard procedures, and quality requirements.

Performs detailed reviews of documentation related to GMP activities.

Routes, tracks and completes documents in the electronic document systems and ensures that entries are accurate and current.

Updates and maintains various databases as needed. Assists with the issuance and maintenance of controlled documents.

Types, scans/copies, distributes/retrieves, and files controlled documents and records as required.

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

Participates in continuous improvement initiatives based on international regulations and industry best practices.

Prioritizing tasks to ensure the critical tasks are completed on time and meet requirements.

Participates in site inspection readiness and the site internal audit program, including site walkthroughs.

Knowledge, Experience & Skills:

A BS or BA degree in a scientific area or a high school diploma and minimum 3 years of relevant experience.

Must be able to think critically and creatively, be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills.

Demonstrates excellent communication (verbal and technical writing) skills and strong interpersonal skills.


For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job 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.

For more information about equal employment opportunity protections, please view the ‘Know Your Rights’ poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

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

For jobs in France:

Conformément à la Loi « Informatique et Libertés » (06/01/78), nous vous informons du fait que les données personnelles renseignées pourront faire l'objet d'un traitement informatique par Gilead et pourront être transmises aux Organismes Sociaux. Par ailleurs, vous disposez d'un droit d'accès, de rectification et de suppression des données vous concernant. Vous pouvez exercer ce droit en contactant: FranceDataPrivacy@gilead.com

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