QA Specialist II

Gilead Sciences; Foster City (CA); On-site; USD 102,000 - 133,000; Full time

Job summary

A leading biotechnology company is seeking a QA Specialist II to handle clinical and commercial complaint investigations. This position involves significant responsibilities including regulatory compliance and maintaining high-quality standards. The ideal candidate will hold a degree in a relevant field and possess extensive experience in a GMP environment, ready to contribute to innovative solutions in life sciences.

Benefits

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Comprehensive benefits package

Company-sponsored medical insurance

Dental and vision insurance

Life insurance plans

Qualifications

• 4+ years relevant experience in a GMP environment with a Bachelor’s degree.
• 2+ years relevant experience with a Master’s degree preferred.
• Prior experience in the pharmaceutical industry is preferred.

Responsibilities

• Responsible for clinical and commercial complaint investigations.
• Leads and coordinates complex complaint investigations.
• Ensures compliance with regulatory requirements and GMP.

Skills

Good Manufacturing Practices (GMPs)

Quality Assurance systems principles

Regulatory compliance

Interpersonal skills

Technical writing

Education

Bachelor’s degree in a relevant field

Master’s degree in a relevant field

Tools

Microsoft Office Applications

Job description

Join to apply for the QA Specialist II role at Gilead Sciences

Join to apply for the QA Specialist II role at Gilead Sciences

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

Specific Job Responsibilities

• Responsible for clinical and commercial complaint investigations.
• Responsible for tracking and trending of complaints across all Gilead Sciences sites and presents data periodically for Quality Management Review
• Leads and co-ordinates complex complaint investigations, including development and implementation of corrective actions.
• Interfaces with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorates. Prepares and presents Complaint data to the regulatory agency inspections.
• Writes and/or implements changes to controlled documents (e.g., SOPs, investigational protocols etc.) as needed.
• Supports Annual Product Quality Reviews, CCPRs and trend analysis reporting related to commercial product complaints.
• Escalates Critical and Major Complaints timely and presents them to senior management.
• Collaborates cross functionally and geographically with stakeholders to ensure alignment of complaint management process.
• Develops an effective working relationship with Gilead Sites, CMOs, and Patient Safety.
• Supports development and implementation of strategic Quality assurance programs and initiatives.
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
• Develops solutions to more complex problems, identifies variance from accepted practice, and evaluates impact as necessary.
• Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks.
• Normally receives no instruction on routine work, general instructions on new assignments.
  
  

Basic Qualifications

• Bachelor’s degree and 4+ years of relevant experience in a GMP environment related field; OR
• Master’s degree and 2 + years of relevant experience
• Prior experience in pharmaceutical industry is preferred
  
  

Preferred Qualifications

• Demonstrates proficiency in Good Manufacturing Practices (GMPs).
• Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards.
• Demonstrates thorough knowledge of FDA/EMEA standards and quality systems and the interface with other functions like manufacturing, distribution and maintenance.
• Demonstrates strong verbal, technical writing and interpersonal skills.
• Demonstrates proficiency in Microsoft Office applications.
  
  

Gilead Core Values

• Integrity (Doing What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)
  
  

The salary range for this position is: $102,085.00 - $132,110.00. 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 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 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 [e-mail] 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 apply via the Internal Career Opportunities portal in Workday.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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