Quality Assurance Operations Specialist II

4 weeks ago

San Mateo, California, United States Gilead Sciences Full time
Job Title: Quality Assurance Operations Specialist II

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.

Job Summary:

We are seeking a Quality Assurance Operations Specialist II to join our team. The successful candidate will be responsible for ensuring compliance with applicable regulatory requirements, developing Standard Operating Procedures (SOPs), and maintaining routine programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs).

Key Responsibilities:
  • Interact with contract manufacturers to resolve quality issues with minimal supervision
  • Perform a wide variety of activities to ensure compliance with applicable regulatory requirements
  • Participate in developing SOPs to ensure quality objectives are met
  • Maintain routine programs and processes to ensure high-quality products and compliance with current GMPs
  • Work directly with CXOs to ensure overall quality compliance on a continuing basis as specified to enforce requirements and meet specifications
  • May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products
  • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products
  • Review and approve master batch records, labels, specifications, and other pre-production documents for clinical Drug Substance (DS) and Drug Product (DP) in compliance with FDA and international health authority requirements
  • Review executed production batch records, environmental monitoring data (as required), analytical data, and associated documentation, including any deviation and investigation reports related to lot release of DS/DP in support of product disposition
Requirements:
  • Good working knowledge of Quality Systems and cGMP standards applicable to clinical development
  • Ability to work on complex, non-routine assignments where analysis of the situation or data requires a review of identifiable factors
  • Ability to effectively participate in cross-functional teams
  • Ability to coordinate the planning, organization, and implementation of project deliverables within specified objectives
  • An accountable team player who is detail and quality oriented with solid understanding of quality assurance principles, systems, and procedures
  • Excellent attitude with strong verbal, written, and interpersonal communication skills
  • Self-starter, able to work independently
  • Able to travel infrequently (less than 5%)
Education and Experience:
  • 4+ years of relevant GMP experience in the Biopharmaceutical or Pharmaceutical industry and a BS
  • 2 + years of relevant GMP experience and a MS
  • Demonstrates working knowledge of current Good Manufacturing Practices (GMPs)
  • 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
Salary and Benefits:

The salary range for this position is: $99,790.00 - $129,140.00. 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:

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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 Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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