QA Specialist I

QA Specialist I
United States - California - San Dimas

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


QA Specialist I

Shift

The shift hours and days for this position are 4pm - 4am Thursday - Saturday, rotating Sunday (see below)

• Thursday, Friday, Saturday - 3x12 shift (4pm to 4am)
• Rotation - Every other Sunday (4pm to 4am)

Essential Functions:

• Will provide on the floor QA oversight and support to ensure compliance of GMP activities throughout the site.
• Direct interface with Manufacturing, Supply & Distribution, Maintenance, Metrology and Quality Control employees to immediately address compliance issues and questions real time.
• Ensures adherence to proper escalation when non-conformances are identified as outlined per applicable procedures.
• Serves as a resource for compliance, escalation and corrections.
• Ensure departmental compliance to procedures, gmp records and associated forms.
• Ensures documentation is recorded in accordance with ALCOA principles.
• Work with operating entities with guidance from senior colleagues to ensure that inspections, statistical processes control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
• May assist with investigations and corrective and preventive actions (CAPA).

Knowledge, Experience & Skills:

• 2+ years of relevant experience in a GMP environment related field and a BS. OR 3+ years of relevant experience and an AA degree.
• Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
• Demonstrates basic knowledge of FDA standards and quality systems.
• Demonstrates good verbal, written, and interpersonal communication skills.
• Demonstrates working knowledge in Microsoft Office applications.
• Demonstrates basic knowledge of FDA standards and quality systems.
• Biopharmaceutical or Pharmaceutical experience preferred.

Shift

• Thursday, Friday, Saturday - 3x12 shift (4pm to 4am)
• Rotation - Every other Sunday (4pm to 4am)

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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' 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 Current Gilead Employees and Contractors:
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